Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Apple Inc. with 9 510(k) clearances and 5 AI-enabled devices. The most recent is a 510(k) clearance dated Apr 1, 2026: Medical Imaging Calibration Feature (MICF).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Apr 1, 2026 | Medical Imaging Calibration Feature (MICF)K253582 · SHN | 510(k) clearances |
| Sep 11, 2025 | Hypertension Notification Feature (HTNF)K250507 · SFR | 510(k) clearances |
| Sep 11, 2025 | Hypertension Notification Feature (HTNF)K250507 · Cardiovascular | AI-enabled devices |
| Jun 23, 2025 | Digital Prism Correction Feature (DPCF)K250143 · SCW | 510(k) clearances |
| Oct 21, 2024 | Digital Prism Correction Feature (DPCF)K242058 · SCW | 510(k) clearances |
| Sep 13, 2024 | Sleep Apnea Notification Feature (SANF)K240929 · QZW | 510(k) clearances |
| Sep 13, 2024 | Sleep Apnea Notification Feature (SANF)K240929 · Anesthesiology | AI-enabled devices |
| Sep 12, 2024 | Hearing Aid Feature (HAF)DEN230081 · SCR | 510(k) clearances |
| Jul 21, 2023 | Irregular Rhythm Notification Feature (IRNF)K231173 · QDB | 510(k) clearances |
| Jul 21, 2023 | Irregular Rhythm Notification Feature (IRNF)K231173 · Cardiovascular | AI-enabled devices |
| Jun 3, 2022 | Atrial Fibrillation History FeatureK213971 · QDB | 510(k) clearances |
| Jun 3, 2022 | Atrial Fibrillation History FeatureK213971 · Cardiovascular | AI-enabled devices |
| Oct 22, 2021 | IRNF AppK212516 · Cardiovascular | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
