Company ยท US
Apple, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| QDB | Photoplethysmograph Analysis Software For Over-The-Counter Use | 4 |
| QDA | Electrocardiograph Software For Over-The-Counter Use | 2 |
| SCW | Digital Prismatic Correction | 2 |
| QZW | Over-The-Counter Device To Assess Risk Of Sleep Apnea | 1 |
| SCR | Air-Conduction Hearing Aid Software | 1 |
| SFR | Hypertension Machine Learning-Based Notification Software | 1 |
| SHN | Calibration Software For Radiology Displays | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 1, 2026 | K253582 | Medical Imaging Calibration Feature (MICF) Apple, Inc. | SHN |
| Sep 11, 2025 | K250507 | Hypertension Notification Feature (HTNF) Apple, Inc. | SFR |
| Jun 23, 2025 | K250143 | Digital Prism Correction Feature (DPCF) Apple, Inc. | SCW |
| Oct 21, 2024 | K242058 | Digital Prism Correction Feature (DPCF) Apple, Inc. | SCW |
| Sep 13, 2024 | K240929 | Sleep Apnea Notification Feature (SANF) Apple, Inc. | QZW |
| Sep 12, 2024 | DEN230081 | Hearing Aid Feature (HAF) Apple, Inc. | SCR |
| Jul 21, 2023 | K231173 | Irregular Rhythm Notification Feature (IRNF) Apple, Inc. | QDB |
| Jun 3, 2022 | K213971 | Atrial Fibrillation History Feature Apple, Inc. | QDB |
| Oct 22, 2021 | K212516 | IRNF App Apple, Inc. | QDB |
| Oct 8, 2020 | K201525 | ECG App Apple, Inc. | QDA |
| Sep 11, 2018 | DEN180044 | ECG App Apple, Inc. | QDA |
| Sep 11, 2018 | DEN180042 | Irregular Rhythm Notification Feature Apple, Inc. | QDB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||