Loss of Pulse Detection

FDA 510(k) K242967 · Fitbit

Substantially Equivalent

510(k) numberK242967

Submission

Device name
Loss of Pulse Detection
Applicant
Fitbit
San Francisco, CA, US
Received
September 26, 2024
Decision date
February 25, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
SDY – Loss Of Pulse Notification Software
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2790
Specialty
Cardiovascular

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.

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Questions and answers

When was Loss of Pulse Detection cleared by the FDA?

Loss of Pulse Detection (K242967) received a 510(k) decision of Substantially Equivalent on February 25, 2025, 152 days after the submission was received.

What is the product code of K242967?

The FDA product code is SDY – Loss Of Pulse Notification Software, a Class II (moderate risk) device regulated under 21 CFR 870.2790.