# DEN230050: Body Temperature Software (BTS)

- Pathway: De Novo (Direct)
- Applicant: Fitbit, LLC
- Decided: Dec 15, 2023 after 151 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K243778: Body Temperature Software (BTS) (2025), 0 descendants of its own

## 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/DEN230050
Methodology: https://510kreport.com/methodology