Company ยท US
Fitbit, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2025. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 25, 2025 | K242967 | Loss of Pulse Detection Fitbit | SDY |
| Feb 13, 2025 | K243778 | Body Temperature Software (BTS) Fitbit, LLC | QZA |
| Dec 15, 2023 | DEN230050 | Body Temperature Software (BTS) Fitbit, LLC | QZA |
| Apr 8, 2022 | K212372 | Fitbit Irregular Rhythm Notifications Fitbit, Inc. | QDB |
| Sep 11, 2020 | K200948 | Fitbit ECG App Fitbit, Inc. | QDA |
| Jun 2, 2014 | K133872 | ARIA WIFI SMART SCALE Fitbit, Inc. | MNW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||