Devices · Fitbit

Loss of Pulse Detection

Fitbit is listed for Loss of Pulse Detection (K242967). The FDA list gives February 25, 2025 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code SDY as “Loss Of Pulse Notification Software”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242967

Official FDA database record

Date of final decision

February 25, 2025

Company on the FDA list

Fitbit

Lead panel

Cardiovascular

Primary product code

SDY

openFDA device name for the code

Loss Of Pulse Notification Software

Device class

2

Regulation number

870.2790

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary