510(k) · Cleared
ClearedBody Temperature Software (BTS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fitbit, LLC · QZA Body Temperature Sensing Software
Cleared on Feb 13, 2025 as substantially equivalent to DEN230050 (Fitbit, LLC, 2023) after a 66-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Feb 13, 2025
- Review
- 66 days
- Class
- Class II
- Product code
- QZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230050 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230050 Body Temperature Software (BTS)Fitbit, LLC · 2023
- This deviceK243778 Body Temperature Software (BTS)Fitbit, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230050 | Body Temperature Software (BTS) | Fitbit, LLC | 2023 | — |
| 0 (this device) | K243778 | Body Temperature Software (BTS) | Fitbit, LLC | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QZA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN230050 | Body Temperature Software (BTS)Summary page 5…subject device is detailed in the table below. Predicate Device De Novo Product Code Manufacturer Trade Name Body Temperature DEN230050 QZA Fitbit LLC Software (BTS) Indications for Use: The Body Temperature Software (BTS) App i… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All QZA devicesQZA Body Temperature Sensing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QZA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QZA
Too few QZA 510(k)s in any year since 2007 to give a median.
Recalls per year · QZA
No recall names QZA since 2007.
Adverse event reports per year · QZA
1in 2025
MAUDE reports naming product code QZA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243778: Body Temperature Software (BTS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243778
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026