# K242967: Loss of Pulse Detection

- Pathway: 510(k) (Traditional)
- Applicant: Fitbit
- Decided: Feb 25, 2025 after 152 days
- Product code: SDY (Loss Of Pulse Notification Software)
- 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)
- K212372: Fitbit Irregular Rhythm Notifications, Fitbit, Inc. (2022) Summary page 5.

## Indications for use
Loss of Pulse Detection is a software-only mobile medical application that is intended to be used with compatible consumer wrist-worn products to analyze pulse data to identify loss of pulse events and provide audio, visual, and haptic alerts to the user. If the user remains unresponsive to these alerts, Loss of Pulse Detection will attempt to prompt a call to emergency services through the user's connected compatible hardware, such as a smartphone or smartwatch. Loss of Pulse Detection is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every loss of pulse event and the absence of an alert is not intended to indicate that no such event has occurred; rather the Loss of Pulse Detection is intended to opportunistically surface an alert of possible loss of pulsatility when sufficient data are available for analysis. These data are only captured when the user is still. Loss of Pulse Detection is not intended to replace traditional methods of diagnosis, treatment, or monitoring. Loss of Pulse Detection 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 a high risk for sudden cardiac death such as those with coronary artery disease, cardiomyopathy and/or unexplained syncope/fainting.

Source page: https://510kreport.com/device/K242967
Methodology: https://510kreport.com/methodology