# Irregular Rhythm Notification Feature (Apple)

Product · id `cardio:apple-irregular-rhythm-notification` · Cardiovascular Atlas · release `5dcd9b263fe17744` (public)

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Also called: Apple Irregular Rhythm Notification Feature; Irregular Rhythm Notification Feature

Browse, condition area: Heart rhythm problems  

## In plain language

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.

## 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.

## Claims, with the population each applies to

## 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)

### 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.

- Category: Regulatory
- Evidence stage: Evidence stage not applicable
- Certainty: Certainty not assessed
- Applies to: 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)
- 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
- Sources:
  1. Supports: FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/510k.json?search=k_number:DEN180042>
     Locator: results\[0\].k\_number. Retrieved 2026-10-14T18:18:41Z. Source state: Current. Snapshot hash: 98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5.
     How it applies: The De Novo number of this record.
  2. Supports: FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/510k.json?search=k_number:DEN180042>
     Locator: results\[0\].device\_name. Retrieved 2026-10-14T18:18:41Z. Source state: Current. Snapshot hash: 98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5.
     How it applies: Names the feature.
  3. Supports: FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/510k.json?search=k_number:DEN180042>
     Locator: results\[0\].applicant. Retrieved 2026-10-14T18:18:41Z. Source state: Current. Snapshot hash: 98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5.
     How it applies: The applicant, as FDA writes the name.
  4. Supports: FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/510k.json?search=k_number:DEN180042>
     Locator: results\[0\].decision\_date. Retrieved 2026-10-14T18:18:41Z. Source state: Current. Snapshot hash: 98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5.
     How it applies: ISO decision date.
  5. Supports: FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/510k.json?search=k_number:DEN180042>
     Locator: results\[0\].date\_received. Retrieved 2026-10-14T18:18:41Z. Source state: Current. Snapshot hash: 98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5.
     How it applies: Date FDA received the request.
  6. Supports: FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/510k.json?search=k_number:DEN180042>
     Locator: results\[0\].product\_code. Retrieved 2026-10-14T18:18:41Z. Source state: Current. Snapshot hash: 98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5.
     How it applies: FDA product code.
  7. Supports: FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/510k.json?search=k_number:DEN180042>
     Locator: results\[0\].openfda.device\_class. Retrieved 2026-10-14T18:18:41Z. Source state: Current. Snapshot hash: 98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5.
     How it applies: Device class as the openFDA block writes it.
  8. Supports: FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/510k.json?search=k_number:DEN180042>
     Locator: results\[0\].openfda.regulation\_number. Retrieved 2026-10-14T18:18:41Z. Source state: Current. Snapshot hash: 98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5.
     How it applies: Regulation number.
  9. Supports: FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/510k.json?search=k_number:DEN180042>
     Locator: results\[0\].openfda.device\_name. Retrieved 2026-10-14T18:18:41Z. Source state: Current. Snapshot hash: 98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5.
     How it applies: FDA name for the device type of the product code.
  10. Supports: FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/510k.json?search=k_number:DEN180042>
     Locator: results\[0\].decision\_code. Retrieved 2026-10-14T18:18:41Z. Source state: Current. Snapshot hash: 98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5.
     How it applies: Decision code DENG.
  11. Background: FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/510k.json?search=k_number:DEN180042>
     Locator: results\[0\].clearance\_type. Retrieved 2026-10-14T18:18:41Z. Source state: Current. Snapshot hash: 98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5.
     How it applies: Clearance type as openFDA records it. This atlas does not explain it.
  12. Background: FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/510k.json?search=k_number:DEN180042>
     Locator: results\[0\].decision\_description. Retrieved 2026-10-14T18:18:41Z. Source state: Current. Snapshot hash: 98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5.
     How it applies: The decision description field reads Unknown.
  13. Supports: FDA Device Classification Under Section 513(f)(2) (De Novo): DEN180042, Irregular Rhythm Notification Feature (Regulator, edition FDA De Novo database page as fetched on 2026-10-14; the page shows Page Last Updated 10/12/2026.) <https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN180042>
     Locator: Page body, Decision. Retrieved 2026-10-14T18:29:15Z. Source state: Current. Snapshot hash: 062aded38844693a1996992e3c48f30eaca1c5bde6f8f51e47c2c35512417ea7.
     How it applies: The FDA database page gives the decision as granted.
  14. Supports: FDA Device Classification Under Section 513(f)(2) (De Novo): DEN180042, Irregular Rhythm Notification Feature (Regulator, edition FDA De Novo database page as fetched on 2026-10-14; the page shows Page Last Updated 10/12/2026.) <https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN180042>
     Locator: Page body, Requester. Retrieved 2026-10-14T18:29:15Z. Source state: Current. Snapshot hash: 062aded38844693a1996992e3c48f30eaca1c5bde6f8f51e47c2c35512417ea7.
     How it applies: The FDA database page calls Apple the requester.
  15. Background: FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record) (Regulator, 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.) <https://api.fda.gov/device/510k.json?search=k_number:DEN180042>
     Locator: meta.disclaimer. Retrieved 2026-10-14T18:18:41Z. Source state: Current. Snapshot hash: 98cee2cfe0c3d7bc5261b9941ea32418a2fc26977ef2c972c67121d7640549a5.
     How it applies: openFDA's own disclaimer about relying on its data.

## Guidance, authorization and access

### Regulatory decision `cardio:regdec-fda-den180042`

- Product: Irregular Rhythm Notification Feature (Apple) (`cardio:apple-irregular-rhythm-notification`)
- Authority: U.S. Food and Drug Administration (`core:fda`)
- Decision: Granted, 2018-09-11
- Product version: Not stated in the FDA records
- Pathway: De Novo
- Submission: DEN180042
- Product code: QDB
- Device class: II
- Indication: Not stated in the fetched FDA records
- Jurisdictions: United States; note: United States
- Applies to: 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)
- Basis: claim `cardio:claim-fda-den180042-granted`

## Connected pages

- An irregular-pulse notification feature on a wearable: Smartwatch irregular-pulse detection (`cardio:wearable-rhythm-detection`)
- Registered as a manufacturing establishment for this feature in the current openFDA listing; also the applicant on De Novo DEN180042: Apple (`cardio:apple`)
- Filed under this front: Devices and monitoring (`cardio:front-devices-and-monitoring`)

## Provenance

Content hash: 9a7db6e38e334629f608d0e936a879ea6235112ccd9f56f6151cb19bdf1cdc76
Last substantive edit: 2026-10-14
Evidence last checked: 2026-10-14