QDB
5 FDA 510(k) clearances · Product code
87 daysmedian time to decision
252 days90th percentile
5clearances measured
FDA profile
- Official device name
- Photoplethysmograph Analysis Software For Over-The-Counter Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2790
- Medical specialty
- Cardiovascular
- FDA definition
- A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Irregular Rhythm Notification Feature (IRNF) (K231173) | Apple, Inc. | 2023-07-21 |
| Atrial Fibrillation History Feature (K213971) | Apple, Inc. | 2022-06-03 |
| Fitbit Irregular Rhythm Notifications (K212372) | Fitbit, Inc. | 2022-04-08 |
| IRNF App (K212516) | Apple, Inc. | 2021-10-22 |
| Irregular Rhythm Notification Feature (DEN180042) | Apple, Inc. | 2018-09-11 |
Track QDB automatically
Every clearance here is in the API, with alerts when new ones post.