# HeartStart OnSite and Home defibrillators

Product · id `cardio:heartstart-onsite-home` · Cardiovascular Atlas · release `73130c34862e2d06` (public)

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Browse, condition area: Acute care and long-term living  

## In plain language

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.

## 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.

## Claims, with the population each applies to

## 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).

### 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.

- Category: Regulatory
- Evidence stage: Evidence stage not applicable
- Certainty: Certainty not assessed
- Applies to: 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).
- 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
- Sources:
  1. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].pma\_number. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: openFDA record field.
  2. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].applicant. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: openFDA record field.
  3. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].trade\_name. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: openFDA record field.
  4. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].generic\_name. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: openFDA record field.
  5. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].product\_code. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: openFDA record field.
  6. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].decision\_date. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: openFDA record field.
  7. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].date\_received. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: openFDA record field.
  8. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].decision\_code. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: openFDA record field.
  9. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].openfda.device\_class. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: openFDA record field.
  10. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].openfda.regulation\_number. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: openFDA record field.
  11. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].expedited\_review\_flag. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: openFDA record field.
  12. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].ao\_statement (fragment 1 of 10). Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: Approval-order statement, as openFDA prints it (fragment).
  13. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].ao\_statement (fragment 2 of 10). Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: Approval-order statement, as openFDA prints it (fragment).
  14. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].ao\_statement (fragment 3 of 10). Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: Approval-order statement, as openFDA prints it (fragment).
  15. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].ao\_statement (fragment 4 of 10). Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: Approval-order statement, as openFDA prints it (fragment).
  16. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].ao\_statement (fragment 5 of 10). Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: Approval-order statement, as openFDA prints it (fragment).
  17. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].ao\_statement (fragment 6 of 10). Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: Approval-order statement, as openFDA prints it (fragment).
  18. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].ao\_statement (fragment 7 of 10). Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: Approval-order statement, as openFDA prints it (fragment).
  19. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].ao\_statement (fragment 8 of 10). Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: Approval-order statement, as openFDA prints it (fragment).
  20. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].ao\_statement (fragment 9 of 10). Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: Approval-order statement, as openFDA prints it (fragment).
  21. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].ao\_statement (fragment 10 of 10). Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: Approval-order statement, as openFDA prints it (fragment).
  22. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: results\[0\].ao\_statement (second use of the child wording). Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: Approval-order statement, as openFDA prints it (fragment).
  23. Background: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: meta.disclaimer. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: openFDA's own disclaimer about relying on its data.
  24. Supports: FDA approval order for PMA P160029 (HeartStart OnSite and Home defibrillators) (Regulator, 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.) <https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160029A.pdf>
     Locator: Approval order, page 1. Retrieved 2026-10-15T14:44:30Z. Source state: Current. Snapshot hash: 0e0077bc0526aa4b9cb42990da0968d4799208406ade60b67b8c04ba1bcec268.
     How it applies: Statement in the cited record.
  25. Supports: FDA approval order for PMA P160029 (HeartStart OnSite and Home defibrillators) (Regulator, 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.) <https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160029A.pdf>
     Locator: Approval order, page 1 (quote 2). Retrieved 2026-10-15T14:44:30Z. Source state: Current. Snapshot hash: 0e0077bc0526aa4b9cb42990da0968d4799208406ade60b67b8c04ba1bcec268.
     How it applies: Statement in the cited record.
  26. Supports: FDA approval order for PMA P160029 (HeartStart OnSite and Home defibrillators) (Regulator, 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.) <https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160029A.pdf>
     Locator: Approval order, page 2, conditions of approval. Retrieved 2026-10-15T14:44:30Z. Source state: Current. Snapshot hash: 0e0077bc0526aa4b9cb42990da0968d4799208406ade60b67b8c04ba1bcec268.
     How it applies: Statement in the cited record.
  27. Supports: FDA approval order for PMA P160029 (HeartStart OnSite and Home defibrillators) (Regulator, 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.) <https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160029A.pdf>
     Locator: Approval order, Re: line. Retrieved 2026-10-15T14:44:30Z. Source state: Current. Snapshot hash: 0e0077bc0526aa4b9cb42990da0968d4799208406ade60b67b8c04ba1bcec268.
     How it applies: Statement in the cited record.
  28. Supports: FDA summary of safety and effectiveness data for PMA P160029 (HeartStart OnSite and Home defibrillators) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext.) <https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160029B.pdf>
     Locator: Section I, device trade name. Retrieved 2026-10-15T14:44:30Z. Source state: Current. Snapshot hash: b695054e90d7c75c86955bab9c86ed9e4d97f83c45027c04813c4784e3cd21f9.
     How it applies: Statement in the cited record.
  29. Supports: FDA summary of safety and effectiveness data for PMA P160029 (HeartStart OnSite and Home defibrillators) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext.) <https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160029B.pdf>
     Locator: Section I, general information. Retrieved 2026-10-15T14:44:30Z. Source state: Current. Snapshot hash: b695054e90d7c75c86955bab9c86ed9e4d97f83c45027c04813c4784e3cd21f9.
     How it applies: Statement in the cited record.
  30. Supports: FDA summary of safety and effectiveness data for PMA P160029 (HeartStart OnSite and Home defibrillators) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext.) <https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160029B.pdf>
     Locator: Section I, general information (quote 2). Retrieved 2026-10-15T14:44:30Z. Source state: Current. Snapshot hash: b695054e90d7c75c86955bab9c86ed9e4d97f83c45027c04813c4784e3cd21f9.
     How it applies: Statement in the cited record.
  31. Supports: FDA summary of safety and effectiveness data for PMA P160029 (HeartStart OnSite and Home defibrillators) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext.) <https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160029B.pdf>
     Locator: Section I, general information (quote 3). Retrieved 2026-10-15T14:44:30Z. Source state: Current. Snapshot hash: b695054e90d7c75c86955bab9c86ed9e4d97f83c45027c04813c4784e3cd21f9.
     How it applies: Statement in the cited record.
  32. Supports: FDA summary of safety and effectiveness data for PMA P160029 (HeartStart OnSite and Home defibrillators) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext.) <https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160029B.pdf>
     Locator: Section I, general information (quote 4). Retrieved 2026-10-15T14:44:30Z. Source state: Current. Snapshot hash: b695054e90d7c75c86955bab9c86ed9e4d97f83c45027c04813c4784e3cd21f9.
     How it applies: Statement in the cited record.
  33. Supports: FDA summary of safety and effectiveness data for PMA P160029 (HeartStart OnSite and Home defibrillators) (Regulator, edition PDF fetched 2026-10-15; text read with pdftotext.) <https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160029B.pdf>
     Locator: Section II, indications for use. Retrieved 2026-10-15T14:44:30Z. Source state: Current. Snapshot hash: b695054e90d7c75c86955bab9c86ed9e4d97f83c45027c04813c4784e3cd21f9.
     How it applies: Statement in the cited record.
  34. Supports: FDA premarket approval P160029: HeartStart OnSite and HeartStart Home defibrillators (openFDA record of the original approval) (Regulator, 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.) <https://api.fda.gov/device/pma.json?search=pma_number:P160029&sort=decision_date:asc&limit=1>
     Locator: meta.results.total. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 6a6d66cfbbf8f363a71e02be6e30a66142cf138cf1f798ed26239acaa4115236.
     How it applies: Statement in the cited record.

## Guidance, authorization and access

### Regulatory decision `cardio:regdec-fda-p160029`

- Product: HeartStart OnSite and Home defibrillators (`cardio:heartstart-onsite-home`)
- Authority: U.S. Food and Drug Administration (`core:fda`)
- Decision: Approval, 2019-06-06
- 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).
- Pathway: PMA
- Submission: P160029
- Product code: NSA
- Device class: III
- 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.
- Jurisdictions: United States; note: United States
- Applies to: 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).
- Basis: claim `cardio:claim-fda-p160029-approval`

## Connected pages

- Public-access and home AED: Automated external defibrillator (AED) (`cardio:automated-external-defibrillator`)
- Filed under this front: Emergency and acute care (`cardio:front-emergency-and-acute-care`)

## Provenance

Content hash: fde4743fe55bbdcdc6fc2828bf1d896efca3309e55e78d560b8b4e5cf5bb94fa
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-15