FDA product code QZA: Body Temperature Sensing Software
QZA is the FDA product code for body temperature sensing software. It is a Class II device, regulated under 21 CFR 880.2915 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under QZA, 1 in the last five years. The average 510(k) review took 66 days (median 66); 66 days on average over the last three years. 1 De Novo request was granted under it.
Definition
Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data.
Classification
| Field | Value |
|---|---|
| Device name | Body Temperature Sensing Software |
| Device class | Class II |
| Regulation | 21 CFR 880.2915 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for QZA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 66 |
Compare with all 510(k) review times · Search every QZA clearance
Top QZA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fitbit, LLC | 1 | 2025-02-13 |
Most recent QZA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243778 | Fitbit, LLC | Body Temperature Software (BTS) | 2025-02-13 | 66 |
Recalls for QZA devices
openFDA lists no recalls for product code QZA.
Frequently asked questions
What is FDA product code QZA?
QZA is the FDA product code for body temperature sensing software. It is a Class II device, regulated under 21 CFR 880.2915 and reviewed by the General Hospital panel.
What device class is QZA?
Class II, regulation 21 CFR 880.2915. Typical premarket route: 510(k).
How long does a 510(k) take for product code QZA?
Across 1 cleared submissions the average was 66 days from receipt to decision (median 66).
Which companies have the most QZA clearances?
Fitbit, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QZA
- Run a recall and safety report across every QZA manufacturer
- Watch product code QZA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times