FDA 510(k) · Fitbit
K243778: Body Temperature Software (BTS) (Fitbit, LLC)
Fitbit, LLC received FDA 510(k) K243778 for Body Temperature Software (BTS), with a decision date of Feb 13, 2025 (substantially equivalent).
Prescription or OTC: OTC parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K243778 |
|---|---|
| Pathway | 510(k) |
| Applicant | Fitbit, LLC |
| Device name | Body Temperature Software (BTS) |
| Product code | QZA: Body Temperature Sensing Software |
| Regulation (21 CFR) | 880.2915 |
| Device class | Class 2 |
| Date received | Dec 9, 2024 |
| Decision date | Feb 13, 2025 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Special |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- DEN230050 Body Temperature Software (BTS) (Fitbit)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code QZA is "Body Temperature Sensing Software", class 2, 21 CFR 880.2915. FDA's definition: "Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data."
Our labels for filtering: claim Other, sensor Wrist PPG. These are heuristics, not FDA fields.