Total clearances
5
2020-09-11 → 2025-02-25
Name variants in FDA filings: Fitbit, Inc. / Fitbit, LLC / Fitbit
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| QZA |
Body Temperature Sensing Software |
Class II |
General Hospital |
2 |
2025-02-13 |
| SDY |
Loss Of Pulse Notification Software |
Class II |
Cardiovascular |
1 |
2025-02-25 |
| QDB |
Photoplethysmograph Analysis Software For Over-The-Counter Use |
Class II |
Cardiovascular |
1 |
2022-04-08 |
| QDA |
Electrocardiograph Software For Over-The-Counter Use |
Class II |
Cardiovascular |
1 |
2020-09-11 |
Filings
All 510(k) clearances (5)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2025-02-25 |
K242967 |
Loss of Pulse Detection |
SDY |
Class II |
Cardiovascular |
| 2025-02-13 |
K243778 |
Body Temperature Software (BTS) |
QZA |
Class II |
General Hospital |
| 2023-12-15 |
DEN230050 |
Body Temperature Software (BTS) |
QZA |
Class II |
General Hospital |
| 2022-04-08 |
K212372 |
Fitbit Irregular Rhythm Notifications |
QDB |
Class II |
Cardiovascular |
| 2020-09-11 |
K200948 |
Fitbit ECG App |
QDA |
Class II |
Cardiovascular |