Data / Medical devices / United States / Apple Inc.
Apple Inc.: FDA-registered device maker in Cupertino, CA, United States, 10 510(k) clearances
Apple Inc. is registered with the FDA (registration 3014343954) in Cupertino, CA, United States. It lists 12 device types. The FDA files 10 510(k) clearances under its listings, the newest dated April 1, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014343954
- Address
- One Apple Park Way, Cupertino, CA, United States, 95014
- Owner or operator
- Apple Inc. (10058630)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 17, 2018
- Registered through
- 2026
- Brand names listed
- Atrial Fibrillation History Feature, Cycle Tracking, Digital Prism Correction Feature (DPCF), ECG App, Electrocardiograph Software For Over-The-Counter Use - ECG app (2), Hearing Aid Feature, Hearing Test Feature (HTF), Hypertension Notification Feature (HTNF) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 1 | Manufacturer | accessdata.fda.gov |
| Air-Conduction Hearing Aid Software | SCR | 2 | Manufacturer | accessdata.fda.gov |
| Audiometer | EWO | 2 | Manufacturer | accessdata.fda.gov |
| Calibration Software For Radiology Displays | SHN | 1 | Manufacturer | accessdata.fda.gov |
| Device, Fertility Diagnostic, Proceptive | LHD | U | Manufacturer | accessdata.fda.gov |
| Digital Prismatic Correction | SCW | 1 | Manufacturer | accessdata.fda.gov |
| Electrocardiograph Software For Over-The-Counter Use | QDA | 2 | Manufacturer | accessdata.fda.gov |
| Hypertension Machine Learning-Based Notification Software | SFR | 2 | Manufacturer | accessdata.fda.gov |
| Lens, Spectacle, Non-Custom (Prescription) | HQG | 1 | Specification developer | accessdata.fda.gov |
| Over-The-Counter Device To Assess Risk Of Sleep Apnea | QZW | 2 | Manufacturer | accessdata.fda.gov |
| Photoplethysmograph Analysis Software For Over-The-Counter Use | QDB | 2 | Manufacturer | accessdata.fda.gov |
| Spectacle, Magnifying | HOI | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 1, 2026 | K253582 | Medical Imaging Calibration Feature (MICF) | SHN | Substantially Equivalent | Apple, Inc. | accessdata.fda.gov |
| September 11, 2025 | K250507 | Hypertension Notification Feature (HTNF) | SFR | Substantially Equivalent | Apple, Inc. | accessdata.fda.gov |
| June 23, 2025 | K250143 | Digital Prism Correction Feature (DPCF) | SCW | Substantially Equivalent | Apple, Inc. | accessdata.fda.gov |
| September 13, 2024 | K240929 | Sleep Apnea Notification Feature (SANF) | QZW | Substantially Equivalent | Apple, Inc. | accessdata.fda.gov |
| September 12, 2024 | DEN230081 | Hearing Aid Feature (HAF) | SCR | Unknown | Apple, Inc. | accessdata.fda.gov |
| June 3, 2022 | K213971 | Atrial Fibrillation History Feature | QDB | Substantially Equivalent | Apple, Inc. | accessdata.fda.gov |
| October 22, 2021 | K212516 | IRNF App | QDB | Substantially Equivalent | Apple, Inc. | accessdata.fda.gov |
| October 8, 2020 | K201525 | ECG App | QDA | Substantially Equivalent | Apple, Inc. | accessdata.fda.gov |
| September 11, 2018 | DEN180044 | ECG App | QDA | Unknown | Apple, Inc. | accessdata.fda.gov |
| September 11, 2018 | DEN180042 | Irregular Rhythm Notification Feature | QDB | Unknown | Apple, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Fertility Diagnostic, Proceptive
- All makers of Lens, Spectacle, Non-Custom (Prescription)
- All makers of Audiometer
- All makers of Spectacle, Magnifying
Updated April 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.