# DEN180042: Irregular Rhythm Notification Feature

- Pathway: De Novo (Direct)
- Applicant: Apple, Inc.
- Decided: Sep 11, 2018 after 33 days
- Product code: QDB (Photoplethysmograph Analysis Software For Over-The-Counter Use)
- Device class: 2
- Regulation: 21 CFR 870.2790
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K212516: IRNF App (2021), 2 descendants of its own
- K230292: Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (2023), 1 descendant of its own
- K212372: Fitbit Irregular Rhythm Notifications (2022), 1 descendant of its own
- K242967: Loss of Pulse Detection (2025), 0 descendants of its own
- K240909: Samsung ECG App v 1.3 (ECG) (2024), 0 descendants of its own

## Indications for use
The Irregular Rhythm Notification Feature is a software-only mobile medical application that is intended to be used with the Apple Watch. The feature analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification to the user. The feature is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user’s risk factors, the feature can be used to supplement the decision for AFib screening. The feature is not intended to replace traditional methods of diagnosis or treatment. The feature has not been tested for and is not intended for use in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with AFib.

Source page: https://510kreport.com/device/DEN180042
Methodology: https://510kreport.com/methodology