Apple Inc.
Cupertino, CA, US
APPLE INC. appears in FDA device records in Cupertino, CA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Apple Inc. between 2020 and 2026. The busiest year on record is 2024, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 3 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253582 | Medical Imaging Calibration Feature (MICF) | SHN | Substantially Equivalent | |
| K250507 | Hypertension Notification Feature (HTNF) | SFR | Substantially Equivalent | |
| K250143 | Digital Prism Correction Feature (DPCF) | SCW | Substantially Equivalent | |
| K242058 | Digital Prism Correction Feature (DPCF) | SCW | Substantially Equivalent | |
| K240929 | Sleep Apnea Notification Feature (SANF) | QZW | Substantially Equivalent | |
| DEN230081 | Hearing Aid Feature (HAF) | SCR | Unknown | |
| K231173 | Irregular Rhythm Notification Feature (IRNF) | QDB | Substantially Equivalent | |
| K213971 | Atrial Fibrillation History Feature | QDB | Substantially Equivalent | |
| K212516 | IRNF App | QDB | Substantially Equivalent | |
| K201525 | ECG App | QDA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014343954 | 3014343954 | APPLE INC. | One Apple Park Way, Cupertino, CA 95014 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- SCRAir-Conduction Hearing Aid Software
- EWOAudiometer
- SHNCalibration Software For Radiology Displays
- LHDDevice, Fertility Diagnostic, Proceptive
- SCWDigital Prismatic Correction
- QDAElectrocardiograph Software For Over-The-Counter Use
- SFRHypertension Machine Learning-Based Notification Software
- HQGLens, Spectacle, Non-Custom (Prescription)
- QZWOver-The-Counter Device To Assess Risk Of Sleep Apnea
- QDBPhotoplethysmograph Analysis Software For Over-The-Counter Use
- HOISpectacle, Magnifying
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Apple Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain