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HeartStart OnSite and Home defibrillators

Two over-the-counter AEDs, the HeartStart OnSite (model M5066A) and the HeartStart Home (model M5068A). FDA first cleared them through its 510(k) route (the OnSite in 2002, the Home in 2004) and approved them through premarket approval in June 2019, after a 2015 FDA order required approval of AEDs of this type. The approval order says each is intended for people who may be in sudden cardiac arrest, who have lost consciousness and are not breathing normally. Adults weighing above 55 pounds (25 kg) are covered. Infants and children under 55 pounds (25 kg) or 8 years of age are covered when the optional infant/child pad cartridge is fitted; if it cannot be had, or the child's age or weight is not known, the order tells the user to go ahead with the adult cartridge. The infant/child cartridge can be sold only on prescription.

  • Product
  • In this atlas

Overview

Technical summary

FDA premarket approval P160029, decided 2019-06-06 (received 2016-07-29), applicant Philips Medical Systems, Inc., product codes NSA and MKJ (pediatric pads), device class 3, regulation number 870.5310, expedited review flag N. The summary of safety and effectiveness says the Home model has been on the market since 2004 (first cleared as K040904) and the OnSite since 2002 (first cleared as K020715), and that P160029 answers FDA's final order of 29 January 2015, under which class III AEDs already marketed in the pre-amendment category had to obtain premarket approval. The approval covers the two defibrillators with the primary battery (M5070A) and the SMART Pads Cartridges for adults (M5071A) and for infants and children (M5072A). The order says sudden cardiac arrest for both models; openFDA's text for the Home model, and the summary, leave out the word sudden. The openFDA data hold 27 records for P160029, the original approval and its supplements; this page covers the original approval only. The current openFDA registration and listing names Philips North America LLC as a manufacturing establishment for the P160029 devices; that listing does not show who made them in 2019.

Product details

Type
Device
Model or formulation
HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A), as the FDA record names them
Version
Original PMA approval P160029 (2019): the two defibrillators with the Primary Battery (M5070A) and the SMART Pads Cartridges for adults (M5071A) and for infants and children (M5072A); product codes NSA and MKJ (pediatric pads). The devices were first cleared by 510(k) in 2002 (OnSite, K020715) and 2004 (Home, K040904). Later supplements are not described here.

Intended-use sources

  1. Background FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

    Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
    Reuse basis
    openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

  2. Background FDA summary of safety and effectiveness data for PMA P160029 (HeartStart OnSite and Home defibrillators)

    Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext.

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    b695054e90d7c75c86955bab9c86ed9e4d97f83c45027c04813c4784e3cd21f9
    Reuse basis
    FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-p160029-ssed.pdf).

Claims and evidence

Context United States premarket approval P160029 for the HeartStart OnSite and HeartStart Home defibrillators

Recipient
Recipient not specified
Population
People who may be in sudden cardiac arrest (the order's wording, for both models), who have lost consciousness and are not breathing normally. Adults weighing above 55 pounds (25 kg) are covered. Infants and children under 55 pounds (25 kg) or 8 years of age are covered when the optional infant/child pad cartridge is fitted; if it cannot be had, or the child's age or weight is not known, the order tells the user to go ahead with the adult pad cartridge. The infant/child pad cartridge can be sold only on prescription.
Care setting
Not stated in the FDA record (the defibrillators with adult pads are sold over the counter).
Geography
United States (decision by the US Food and Drug Administration).
Life stage
The order uses weight and age limits instead of one age range: adults above 55 pounds (25 kg); infants and children under 55 pounds (25 kg) or 8 years of age with the optional infant/child pads.
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (regulatory decision).
Eligibility: 3 inclusion criteria; exclusion criteria not stated
Included
  • A person who has lost consciousness and is not breathing normally, in a possible sudden cardiac arrest
  • Adults weighing above 55 pounds (25 kg)
  • Infants and children under 55 pounds (25 kg) or 8 years of age, when the optional infant/child pad cartridge is fitted (the order says to go ahead with the adult cartridge if it cannot be had or the child's age or weight is not known)
Excluded
None stated

  • Regulatory Evidence stage not applicable Certainty not assessed

    The US Food and Drug Administration approved premarket approval application P160029 for the HeartStart OnSite Defibrillator (Model M5066A) and the HeartStart Home Defibrillator (Model M5068A) on 6 June 2019, after receiving it on 29 July 2016. The summary of safety and effectiveness says the Home model had been on the market since 2004 (first cleared under 510(k) K040904) and the OnSite model since 2002 (K020715). It says the application answered FDA's final order of 29 January 2015, under which class III AEDs already marketed in the pre-amendment category had to obtain premarket approval, for product codes NSA and MKJ (the latter for pediatric pads). The approval order lists the primary battery (Model M5070A) and the SMART Pads Cartridges for adults (Model M5071A) and for infants and children (Model M5072A) with the two defibrillators, and gives product codes NSA and MKJ (the latter for pediatric pads). The openFDA record names Philips Medical Systems, Inc. as applicant and gives the generic name over-the-counter automated external defibrillator, product code NSA, device class 3, regulation number 870.5310 and an expedited review flag of N. The approval order says each model is intended for people who may be in sudden cardiac arrest, who have lost consciousness and are not breathing normally. Adults weighing above 55 pounds (25 kg) are covered. Infants and children under 55 pounds (25 kg) or 8 years of age are covered when the optional infant/child pad cartridge (M5072A) is fitted. If that cartridge cannot be had, or the child's age or weight is not known, the order tells the user to go ahead with the adult pad cartridge (M5071A). The infant/child pad cartridge can be sold only on prescription.

    Applies to Recipient not specified
    • People who may be in sudden cardiac arrest (the order's wording, for both models), who have lost consciousness and are not breathing normally. Adults weighing above 55 pounds (25 kg) are covered. Infants and children under 55 pounds (25 kg) or 8 years of age are covered when the optional infant/child pad cartridge is fitted; if it cannot be had, or the child's age or weight is not known, the order tells the user to go ahead with the adult pad cartridge. The infant/child pad cartridge can be sold only on prescription.
    • Not stated in the FDA record (the defibrillators with adult pads are sold over the counter).
    • United States (decision by the US Food and Drug Administration).
    • The order uses weight and age limits instead of one age range: adults above 55 pounds (25 kg); infants and children under 55 pounds (25 kg) or 8 years of age with the optional infant/child pads.
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory decision).
    Certainty method
    Not assessed
    Limitations
    This is the original PMA approval, not the first US authorization of these devices. The openFDA data hold 27 records for P160029, the original and its supplements, which are not described here. openFDA's text for the Home model, and the summary of safety and effectiveness for both models, say cardiac arrest where the approval order says sudden cardiac arrest. The approval statement sets who the devices are intended for; it does not state that they improve survival. The FDA documents are cite-only here, so their wording is restated and not quoted. openFDA data are unvalidated, and its own disclaimer says not to rely on them for medical decisions.
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (34)

    1. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].pma_number
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    2. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].applicant
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    3. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].trade_name
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    4. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].generic_name
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    5. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].product_code
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    6. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].decision_date
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    7. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].date_received
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    8. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].decision_code
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    9. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].openfda.device_class
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    10. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].openfda.regulation_number
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    11. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].expedited_review_flag
      How it applies
      openFDA record field.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    12. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].ao_statement (fragment 1 of 10)
      How it applies
      Approval-order statement, as openFDA prints it (fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    13. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].ao_statement (fragment 2 of 10)
      How it applies
      Approval-order statement, as openFDA prints it (fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    14. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].ao_statement (fragment 3 of 10)
      How it applies
      Approval-order statement, as openFDA prints it (fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    15. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].ao_statement (fragment 4 of 10)
      How it applies
      Approval-order statement, as openFDA prints it (fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    16. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].ao_statement (fragment 5 of 10)
      How it applies
      Approval-order statement, as openFDA prints it (fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    17. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].ao_statement (fragment 6 of 10)
      How it applies
      Approval-order statement, as openFDA prints it (fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    18. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].ao_statement (fragment 7 of 10)
      How it applies
      Approval-order statement, as openFDA prints it (fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    19. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].ao_statement (fragment 8 of 10)
      How it applies
      Approval-order statement, as openFDA prints it (fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    20. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].ao_statement (fragment 9 of 10)
      How it applies
      Approval-order statement, as openFDA prints it (fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    21. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].ao_statement (fragment 10 of 10)
      How it applies
      Approval-order statement, as openFDA prints it (fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    22. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      results[0].ao_statement (second use of the child wording)
      How it applies
      Approval-order statement, as openFDA prints it (fragment).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    23. Background FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      meta.disclaimer
      How it applies
      openFDA's own disclaimer about relying on its data.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

    24. Supports FDA approval order for PMA P160029 (HeartStart OnSite and Home defibrillators)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext. The file holds a corrective letter (the OnSite model number was misprinted as M6066A in the trade name) followed by the approval order of 2019-06-06.

      Locator
      Approval order, page 1
      How it applies
      Statement in the cited record.
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      Current
      Snapshot hash
      0e0077bc0526aa4b9cb42990da0968d4799208406ade60b67b8c04ba1bcec268
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-p160029-order.pdf).

    25. Supports FDA approval order for PMA P160029 (HeartStart OnSite and Home defibrillators)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext. The file holds a corrective letter (the OnSite model number was misprinted as M6066A in the trade name) followed by the approval order of 2019-06-06.

      Locator
      Approval order, page 1 (quote 2)
      How it applies
      Statement in the cited record.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0e0077bc0526aa4b9cb42990da0968d4799208406ade60b67b8c04ba1bcec268
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-p160029-order.pdf).

    26. Supports FDA approval order for PMA P160029 (HeartStart OnSite and Home defibrillators)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext. The file holds a corrective letter (the OnSite model number was misprinted as M6066A in the trade name) followed by the approval order of 2019-06-06.

      Locator
      Approval order, page 2, conditions of approval
      How it applies
      Statement in the cited record.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0e0077bc0526aa4b9cb42990da0968d4799208406ade60b67b8c04ba1bcec268
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-p160029-order.pdf).

    27. Supports FDA approval order for PMA P160029 (HeartStart OnSite and Home defibrillators)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext. The file holds a corrective letter (the OnSite model number was misprinted as M6066A in the trade name) followed by the approval order of 2019-06-06.

      Locator
      Approval order, Re: line
      How it applies
      Statement in the cited record.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0e0077bc0526aa4b9cb42990da0968d4799208406ade60b67b8c04ba1bcec268
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-p160029-order.pdf).

    28. Supports FDA summary of safety and effectiveness data for PMA P160029 (HeartStart OnSite and Home defibrillators)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext.

      Locator
      Section I, device trade name
      How it applies
      Statement in the cited record.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      b695054e90d7c75c86955bab9c86ed9e4d97f83c45027c04813c4784e3cd21f9
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-p160029-ssed.pdf).

    29. Supports FDA summary of safety and effectiveness data for PMA P160029 (HeartStart OnSite and Home defibrillators)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext.

      Locator
      Section I, general information
      How it applies
      Statement in the cited record.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      b695054e90d7c75c86955bab9c86ed9e4d97f83c45027c04813c4784e3cd21f9
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-p160029-ssed.pdf).

    30. Supports FDA summary of safety and effectiveness data for PMA P160029 (HeartStart OnSite and Home defibrillators)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext.

      Locator
      Section I, general information (quote 2)
      How it applies
      Statement in the cited record.
      Retrieved
      Source effective date
      Not reported
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      Current
      Snapshot hash
      b695054e90d7c75c86955bab9c86ed9e4d97f83c45027c04813c4784e3cd21f9
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-p160029-ssed.pdf).

    31. Supports FDA summary of safety and effectiveness data for PMA P160029 (HeartStart OnSite and Home defibrillators)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext.

      Locator
      Section I, general information (quote 3)
      How it applies
      Statement in the cited record.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      b695054e90d7c75c86955bab9c86ed9e4d97f83c45027c04813c4784e3cd21f9
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-p160029-ssed.pdf).

    32. Supports FDA summary of safety and effectiveness data for PMA P160029 (HeartStart OnSite and Home defibrillators)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext.

      Locator
      Section I, general information (quote 4)
      How it applies
      Statement in the cited record.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      b695054e90d7c75c86955bab9c86ed9e4d97f83c45027c04813c4784e3cd21f9
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-p160029-ssed.pdf).

    33. Supports FDA summary of safety and effectiveness data for PMA P160029 (HeartStart OnSite and Home defibrillators)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-15; text read with pdftotext.

      Locator
      Section II, indications for use
      How it applies
      Statement in the cited record.
      Retrieved
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      Not reported
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      Current
      Snapshot hash
      b695054e90d7c75c86955bab9c86ed9e4d97f83c45027c04813c4784e3cd21f9
      Reuse basis
      FDA document fetched 2026-10-15 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed (fetched as ck-fda-p160029-ssed.pdf).

    34. Supports FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The earliest of the 27 openFDA PMA records for P160029 by decision date (2019-06-06), taken as the original approval. The later records are supplements and are not described here. · PMA: P160029

      Locator
      meta.results.total
      How it applies
      Statement in the cited record.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-15 as ck-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/ck-openfda-pma-P160029.json. It includes address and registration fields that FDA publishes; records here do not repeat them.

Authorization

Regulatory decision: HeartStart OnSite and Home defibrillators

Applies to Recipient not specified
  • People who may be in sudden cardiac arrest (the order's wording, for both models), who have lost consciousness and are not breathing normally. Adults weighing above 55 pounds (25 kg) are covered. Infants and children under 55 pounds (25 kg) or 8 years of age are covered when the optional infant/child pad cartridge is fitted; if it cannot be had, or the child's age or weight is not known, the order tells the user to go ahead with the adult pad cartridge. The infant/child pad cartridge can be sold only on prescription.
  • Not stated in the FDA record (the defibrillators with adult pads are sold over the counter).
  • United States (decision by the US Food and Drug Administration).
  • The order uses weight and age limits instead of one age range: adults above 55 pounds (25 kg); infants and children under 55 pounds (25 kg) or 8 years of age with the optional infant/child pads.
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory decision).
Authority
U.S. Food and Drug Administration
Decision
Approval,
Pathway
PMA
Submission
P160029
Product code
NSA
Device class
Class III
Jurisdictions
United States; note: United States
Product version
HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A), with the Primary Battery (M5070A) and the SMART Pads Cartridges for adults (M5071A) and for infants and children (M5072A); the 2019 PMA approval, not later supplements. The order also lists product code MKJ (pediatric pads).
Indication
People who may be in sudden cardiac arrest, who have lost consciousness and are not breathing normally, for both the OnSite (model M5066A) and Home (model M5068A) defibrillators (approval order, restated). Adults weighing above 55 pounds (25 kg); infants and children under 55 pounds (25 kg) or 8 years of age when the optional infant/child pad cartridge (M5072A) is fitted; if it cannot be had, or the child's age or weight is not known, the order tells the user to go ahead with the adult pad cartridge (M5071A). The infant/child pad cartridge can be sold only on prescription.
Basis
The US Food and Drug Administration approved premarket approval application P160029 for the HeartStart OnSite Defibrillator (Model M5066A) and the HeartStart Home Defibrillator (Model M5068A) on 6 June 2019, after receiving it on 29 July 2016. The summary of safety and effectiveness says the Home model had been on the market since 2004 (first cleared under 510(k) K040904) and the OnSite model since 2002 (K020715). It says the application answered FDA's final order of 29 January 2015, under which class III AEDs already marketed in the pre-amendment category had to obtain premarket approval, for product codes NSA and MKJ (the latter for pediatric pads). The approval order lists the primary battery (Model M5070A) and the SMART Pads Cartridges for adults (Model M5071A) and for infants and children (Model M5072A) with the two defibrillators, and gives product codes NSA and MKJ (the latter for pediatric pads). The openFDA record names Philips Medical Systems, Inc. as applicant and gives the generic name over-the-counter automated external defibrillator, product code NSA, device class 3, regulation number 870.5310 and an expedited review flag of N. The approval order says each model is intended for people who may be in sudden cardiac arrest, who have lost consciousness and are not breathing normally. Adults weighing above 55 pounds (25 kg) are covered. Infants and children under 55 pounds (25 kg) or 8 years of age are covered when the optional infant/child pad cartridge (M5072A) is fitted. If that cartridge cannot be had, or the child's age or weight is not known, the order tells the user to go ahead with the adult pad cartridge (M5071A). The infant/child pad cartridge can be sold only on prescription.

Limitations. This is the original PMA approval, not the first US authorization of these devices. The openFDA data hold 27 records for P160029, the original and its supplements, which are not described here. openFDA's text for the Home model, and the summary of safety and effectiveness for both models, say cardiac arrest where the approval order says sudden cardiac arrest. The approval statement sets who the devices are intended for; it does not state that they improve survival. The FDA documents are cite-only here, so their wording is restated and not quoted. openFDA data are unvalidated, and its own disclaimer says not to rely on them for medical decisions.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Record details

Record id
cardio:heartstart-onsite-home
Content hash
fde4743fe55bbdcdc6fc2828bf1d896efca3309e55e78d560b8b4e5cf5bb94fa