# K212372: Fitbit Irregular Rhythm Notifications

- Pathway: 510(k) (Traditional)
- Applicant: Fitbit, Inc.
- Decided: Apr 8, 2022 after 252 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: 1 generation back to DEN180042 (2018). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180042: Irregular Rhythm Notification Feature, Apple, Inc. (2018) Summary page 4.

## Most influential descendants
- K242967: Loss of Pulse Detection (2025), 0 descendants of its own

## Indications for use
The Fitbit Irregular Rhythm Notifications is a software-only mobile medical application that is intended to be used with compatible consumer wrist-worn products to analyze pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provide a notification to the user. The Fitbit Irregular Rhythm Notifications 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 Fitbit Irregular Rhythm Notifications 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 Fitbit Irregular Rhythm Notifications can be used to supplement the decision for AFib screening. The Fitbit Irregular Rhythm Notifications is not intended to replace traditional methods of diagnosis or treatment. The Fitbit Irregular Rhythm Notifications 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/K212372
Methodology: https://510kreport.com/methodology