Fitbit
Fitbit appears in FDA public data with 0 recalls, 6 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on February 25, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 6
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K242967 | Loss of Pulse Detection | February 25, 2025 |
| K243778 | Body Temperature Software (BTS) | February 13, 2025 |
| DEN230050 | Body Temperature Software (BTS) | December 15, 2023 |
| K212372 | Fitbit Irregular Rhythm Notifications | April 8, 2022 |
| K200948 | Fitbit ECG App | September 11, 2020 |
| K133872 | ARIA WIFI SMART SCALE | June 2, 2014 |