Body Temperature Software (BTS)

FDA 510(k) K243778 · Fitbit, LLC

Substantially Equivalent

510(k) numberK243778

Submission

Device name
Body Temperature Software (BTS)
Applicant
Fitbit, LLC
San Francisco, CA, US
Received
December 9, 2024
Decision date
February 13, 2025
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QZA – Body Temperature Sensing Software
Device class
Class II (moderate risk)
Regulation
21 CFR 880.2915
Specialty
General Hospital

Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data.

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Questions and answers

When was Body Temperature Software (BTS) cleared by the FDA?

Body Temperature Software (BTS) (K243778) received a 510(k) decision of Substantially Equivalent on February 13, 2025, 66 days after the submission was received.

What is the product code of K243778?

The FDA product code is QZA – Body Temperature Sensing Software, a Class II (moderate risk) device regulated under 21 CFR 880.2915.