# K243778: Body Temperature Software (BTS)

- Pathway: 510(k) (Special)
- Applicant: Fitbit, LLC
- Decided: Feb 13, 2025 after 66 days
- Product code: QZA (Body Temperature Sensing Software)
- Device class: 2
- Regulation: 21 CFR 880.2915
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230050 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230050: Body Temperature Software (BTS), Fitbit, LLC (2023) Summary page 5.

## Indications for use
The Body Temperature Software (BTS) App is a software-only mobile medical application intended for over-the-counter (OTC) use with compatible mobile computing platforms that includes a general purpose infrared sensor for the intermittent determination of human body temperature on people of all ages.

Source page: https://510kreport.com/device/K243778
Methodology: https://510kreport.com/methodology