Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Apple, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
135 daysmedian FDA review time
202 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253582 | Medical Imaging Calibration Feature (MICF) | Apple, Inc. | 2026-04-01 | 135 | 0 |
| K250507 | Hypertension Notification Feature (HTNF) | Apple, Inc. | 2025-09-11 | 202 | 0 |
| K250143 | Digital Prism Correction Feature (DPCF) | Apple, Inc. | 2025-06-23 | 157 | 0 |
| K242058 | Digital Prism Correction Feature (DPCF) | Apple, Inc. | 2024-10-21 | 98 | 0 |
| K240929 | Sleep Apnea Notification Feature (SANF) | Apple, Inc. | 2024-09-13 | 162 | 0 |
| DEN230081 | Hearing Aid Feature (HAF) | Apple, Inc. | 2024-09-12 | 283 | 0 |
| K231173 | Irregular Rhythm Notification Feature (IRNF) | Apple, Inc. | 2023-07-21 | 87 | 0 |
| K213971 | Atrial Fibrillation History Feature | Apple, Inc. | 2022-06-03 | 165 | 0 |
| K212516 | IRNF App | Apple, Inc. | 2021-10-22 | 73 | 0 |
| K201525 | ECG App | Apple, Inc. | 2020-10-08 | 122 | 0 |
| DEN180044 | ECG App | Apple, Inc. | 2018-09-11 | 28 | 0 |
| DEN180042 | Irregular Rhythm Notification Feature | Apple, Inc. | 2018-09-11 | 33 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda