IRNF App
by Apple Inc.
510(k) K212516
IRNF App is a Class II device made by Apple Inc., cleared under FDA 510(k) K212516 on 22 Oct 2021, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212516 | Date22 Oct 2021 | StatusActive |
Official records
- FDA 510(k) database K212516
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QDB
- FDA applicant
- Apple, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2790
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K212516
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Irregular Rhythm Notification feature 2.0 Feature Version 2.x | Feature Version 2.x | 00194252456774 | — | On the market |
| Irregular Rhythm Notification feature 2.0 Feature Version 2.x | Feature Version 2.x | 00194252456781 | — | On the market |
Similar devices
Other devices filed under FDA product code QDB (Photoplethysmograph Analysis Software For Over-The-Counter Use).