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Irregular Rhythm Notification Feature (Apple)

An Apple feature that FDA names the Irregular Rhythm Notification Feature. The US Food and Drug Administration granted Apple's De Novo request for it in September 2018, and names its device type photoplethysmograph analysis software for over-the-counter use. The FDA records read do not describe what the feature does or who it is for. The Apple Heart Study tested a smartwatch alert for an irregular pulse: 34% of notified participants who returned an analyzable ECG patch had atrial fibrillation on it. That study used its own research app, and the sources read do not say how it relates to this feature.

Also called Apple Irregular Rhythm Notification Feature · Irregular Rhythm Notification Feature

  • Product
  • In this atlas

Overview

Technical summary

FDA De Novo DEN180042, decided 2018-09-11 (received 2018-08-09), applicant Apple, Inc. (the FDA database page calls it the requester). Product code QDB, class 2, regulation number 870.2790; FDA's device-type name for the code is photoplethysmograph analysis software for over-the-counter use. The openFDA record gives no indications-for-use text, no model and no version. The openFDA registration and listing records name Apple Inc. as a manufacturing establishment for the feature under DEN180042; that listing is current and does not show who made it in 2018. The registry intervention of the Apple Heart Study is the study's own app and not this feature.

Product details

Type
Software
Model or formulation
Irregular Rhythm Notification Feature
Version
Not stated in the FDA records

Intended-use sources

No intended-use source is recorded.

Claims and evidence

Context United States De Novo record DEN180042 for the Irregular Rhythm Notification Feature

Recipient
Recipient not specified
Population
Not stated in the FDA records. They name a feature, an applicant and a product code, and give no intended population.
Care setting
Not stated in the FDA records
Geography
United States (decision by the US Food and Drug Administration)
Life stage
Not stated in the FDA records
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (regulatory decision)
Eligibility: inclusion criteria not stated; exclusion criteria not stated
Included
None stated
Excluded
None stated

  • Regulatory Evidence stage not applicable Certainty not assessed

    The US Food and Drug Administration granted De Novo request DEN180042 for the Irregular Rhythm Notification Feature on 11 September 2018, after receiving it on 9 August 2018. The openFDA record names Apple, Inc. as applicant and gives product code QDB, device class 2 and regulation number 870.2790. It gives the FDA product-code device name as photoplethysmograph analysis software for over-the-counter use. The FDA database page gives the decision as granted (DENG) and calls Apple the requester. In the openFDA record the clearance type is Direct and the decision description reads Unknown.

    Applies to Recipient not specified
    • Not stated in the FDA records. They name a feature, an applicant and a product code, and give no intended population.
    • Not stated in the FDA records
    • United States (decision by the US Food and Drug Administration)
    • Not stated in the FDA records
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory decision)
    Certainty method
    Not assessed
    Limitations
    The fetched records give no indications-for-use text, so the intended population and use are not stated here. A De Novo grant is a regulatory decision about a device type. It is not a finding about how accurate the feature is for any person or in everyday use. The Apple Heart Study tested the study's own research app, and the sources read do not say how it relates to the authorized feature, so the study is not evidence about this feature. openFDA data are unvalidated, and the decision description field reads Unknown.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (15)

    1. Supports FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint returns De Novo decisions under their DEN numbers. Record returned on 2026-10-14, from a dataset last updated 2026-10-05. · De Novo: DEN180042

      Locator
      results[0].k_number
      How it applies
      The De Novo number of this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-510k-den180042.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    2. Supports FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint returns De Novo decisions under their DEN numbers. Record returned on 2026-10-14, from a dataset last updated 2026-10-05. · De Novo: DEN180042

      Locator
      results[0].device_name
      How it applies
      Names the feature.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-510k-den180042.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    3. Supports FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint returns De Novo decisions under their DEN numbers. Record returned on 2026-10-14, from a dataset last updated 2026-10-05. · De Novo: DEN180042

      Locator
      results[0].applicant
      How it applies
      The applicant, as FDA writes the name.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-510k-den180042.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    4. Supports FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint returns De Novo decisions under their DEN numbers. Record returned on 2026-10-14, from a dataset last updated 2026-10-05. · De Novo: DEN180042

      Locator
      results[0].decision_date
      How it applies
      ISO decision date.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-510k-den180042.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    5. Supports FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint returns De Novo decisions under their DEN numbers. Record returned on 2026-10-14, from a dataset last updated 2026-10-05. · De Novo: DEN180042

      Locator
      results[0].date_received
      How it applies
      Date FDA received the request.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-510k-den180042.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    6. Supports FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint returns De Novo decisions under their DEN numbers. Record returned on 2026-10-14, from a dataset last updated 2026-10-05. · De Novo: DEN180042

      Locator
      results[0].product_code
      How it applies
      FDA product code.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-510k-den180042.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    7. Supports FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint returns De Novo decisions under their DEN numbers. Record returned on 2026-10-14, from a dataset last updated 2026-10-05. · De Novo: DEN180042

      Locator
      results[0].openfda.device_class
      How it applies
      Device class as the openFDA block writes it.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-510k-den180042.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    8. Supports FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint returns De Novo decisions under their DEN numbers. Record returned on 2026-10-14, from a dataset last updated 2026-10-05. · De Novo: DEN180042

      Locator
      results[0].openfda.regulation_number
      How it applies
      Regulation number.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-510k-den180042.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    9. Supports FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint returns De Novo decisions under their DEN numbers. Record returned on 2026-10-14, from a dataset last updated 2026-10-05. · De Novo: DEN180042

      Locator
      results[0].openfda.device_name
      How it applies
      FDA name for the device type of the product code.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-510k-den180042.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    10. Supports FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint returns De Novo decisions under their DEN numbers. Record returned on 2026-10-14, from a dataset last updated 2026-10-05. · De Novo: DEN180042

      Locator
      results[0].decision_code
      How it applies
      Decision code DENG.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-510k-den180042.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    11. Background FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint returns De Novo decisions under their DEN numbers. Record returned on 2026-10-14, from a dataset last updated 2026-10-05. · De Novo: DEN180042

      Locator
      results[0].clearance_type
      How it applies
      Clearance type as openFDA records it. This atlas does not explain it.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-510k-den180042.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    12. Background FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint returns De Novo decisions under their DEN numbers. Record returned on 2026-10-14, from a dataset last updated 2026-10-05. · De Novo: DEN180042

      Locator
      results[0].decision_description
      How it applies
      The decision description field reads Unknown.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-510k-den180042.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

    13. Supports FDA Device Classification Under Section 513(f)(2) (De Novo): DEN180042, Irregular Rhythm Notification Feature

      Regulator · U.S. Food and Drug Administration · Edition FDA De Novo database page as fetched on 2026-10-14; the page shows Page Last Updated 10/12/2026.

      Locator
      Page body, Decision
      How it applies
      The FDA database page gives the decision as granted.
      Retrieved
      Source effective date
      2026-10-12
      Source state
      Current
      Snapshot hash
      062aded38844693a1996992e3c48f30eaca1c5bde6f8f51e47c2c35512417ea7
      Reuse basis
      Page of the FDA database site (accessdata.fda.gov), fetched as cf-fda-denovo-DEN180042.html. Only the hash is kept. FDA's website policy page (fetched 2026-10-14 as cf-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says the contents of www.fda.gov are in the public domain. This page is on the FDA database host, accessdata.fda.gov, which the policy page does not name, so the terms for this host are unverified and public text is cite_only until the integration owner confirms them.

    14. Supports FDA Device Classification Under Section 513(f)(2) (De Novo): DEN180042, Irregular Rhythm Notification Feature

      Regulator · U.S. Food and Drug Administration · Edition FDA De Novo database page as fetched on 2026-10-14; the page shows Page Last Updated 10/12/2026.

      Locator
      Page body, Requester
      How it applies
      The FDA database page calls Apple the requester.
      Retrieved
      Source effective date
      2026-10-12
      Source state
      Current
      Snapshot hash
      062aded38844693a1996992e3c48f30eaca1c5bde6f8f51e47c2c35512417ea7
      Reuse basis
      Page of the FDA database site (accessdata.fda.gov), fetched as cf-fda-denovo-DEN180042.html. Only the hash is kept. FDA's website policy page (fetched 2026-10-14 as cf-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says the contents of www.fda.gov are in the public domain. This page is on the FDA database host, accessdata.fda.gov, which the policy page does not name, so the terms for this host are unverified and public text is cite_only until the integration owner confirms them.

    15. Background FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint returns De Novo decisions under their DEN numbers. Record returned on 2026-10-14, from a dataset last updated 2026-10-05. · De Novo: DEN180042

      Locator
      meta.disclaimer
      How it applies
      openFDA's own disclaimer about relying on its data.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cf-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/cf-openfda-510k-den180042.json. It includes contact, address and registration fields that FDA publishes; records here do not repeat them.

Authorization

Regulatory decision: Irregular Rhythm Notification Feature (Apple)

Applies to Recipient not specified
  • Not stated in the FDA records. They name a feature, an applicant and a product code, and give no intended population.
  • Not stated in the FDA records
  • United States (decision by the US Food and Drug Administration)
  • Not stated in the FDA records
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory decision)
Authority
U.S. Food and Drug Administration
Decision
Granted,
Pathway
De Novo
Submission
DEN180042
Product code
QDB
Device class
Class II
Jurisdictions
United States; note: United States
Product version
Not stated in the FDA records
Indication
Not stated in the fetched FDA records
Basis
The US Food and Drug Administration granted De Novo request DEN180042 for the Irregular Rhythm Notification Feature on 11 September 2018, after receiving it on 9 August 2018. The openFDA record names Apple, Inc. as applicant and gives product code QDB, device class 2 and regulation number 870.2790. It gives the FDA product-code device name as photoplethysmograph analysis software for over-the-counter use. The FDA database page gives the decision as granted (DENG) and calls Apple the requester. In the openFDA record the clearance type is Direct and the decision description reads Unknown.

Limitations. The fetched records give no indications-for-use text, so the intended population and use are not stated here. A De Novo grant is a regulatory decision about a device type. It is not a finding about how accurate the feature is for any person or in everyday use. The Apple Heart Study tested the study's own research app, and the sources read do not say how it relates to the authorized feature, so the study is not evidence about this feature. openFDA data are unvalidated, and the decision description field reads Unknown.

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

Record details

Record id
cardio:apple-irregular-rhythm-notification
Content hash
9a7db6e38e334629f608d0e936a879ea6235112ccd9f56f6151cb19bdf1cdc76