Is Loss of Pulse Detection FDA cleared?

FDA's records list K242967 for Loss of Pulse Detection from Fitbit: 510(k), decision date Feb 25, 2025, decision "Substantially Equivalent". The 510(k) pathway means the device was cleared, not approved.

What product code is K242967?

SDY: Loss Of Pulse Notification Software, regulated under 21 CFR 870.2790, class 2.

FDA 510(k) · Fitbit

K242967: Loss of Pulse Detection (Fitbit)

Fitbit received FDA 510(k) K242967 for Loss of Pulse Detection, with a decision date of Feb 25, 2025 (substantially equivalent).

Prescription or OTC: OTC parsed from FDA documents (summary PDF: Form 3881 Type of Use (parsed))

FDA record for K242967 FDA summary or statement (PDF)

FDA facts

Official fields for K242967
FDA number	K242967
Pathway	510(k)
Applicant	Fitbit
Device name	Loss of Pulse Detection
Product code	SDY: Loss Of Pulse Notification Software
Regulation (21 CFR)	870.2790
Device class	Class 2
Date received	Sep 26, 2024
Decision date	Feb 25, 2025
Decision	Substantially Equivalent (SESE)
510(k) type	Traditional

Source: openFDA device 510(k) data, data through Oct 26, 2026.

Indications for use parsed from FDA documents

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.

Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.

Predicates parsed from FDA documents

FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.

K212372 Fitbit Irregular Rhythm Notifications (Fitbit)

ChatPPG interpretation

A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.

Product code SDY is "Loss Of Pulse Notification Software", class 2, 21 CFR 870.2790. FDA's definition: "A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying loss of pulse. This device is not intended to provide a diagnosis."

Our labels for filtering: claim Heart rate / pulse, sensor Wrist PPG. These are heuristics, not FDA fields.