# K213971: Atrial Fibrillation History Feature

- Pathway: 510(k) (Traditional)
- Applicant: Apple, Inc.
- Decided: Jun 3, 2022 after 165 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
Longest line of descent: 2 generations back to DEN180042 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212516: IRNF App, Apple, Inc. (2021) Summary page 4.

## Indications for use
The Atrial Fibrillation (AFib) History Feature is an over-the-counter (“OTC”) software-only mobile medical application intended for users 22 years of age and over who have a diagnosis of atrial fibrillation (AFib). The feature opportunistically analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides the user with a retrospective estimate of AFib burden (a measure of the amount of time spent in AFib during past Apple Watch wear). The feature also tracks and trends estimated AFib burden over time, and includes lifestyle data visualizations to enable users to understand the impact of certain aspects of their lifestyle on their AFib. It is not intended to provide individual irregular rhythm notifications or to replace traditional methods of diagnosis, treatment, or monitoring of AFib. The feature is intended for use with the Apple Watch and the Health app on iPhone.

Source page: https://510kreport.com/device/K213971
Methodology: https://510kreport.com/methodology