Apple, Inc.: FDA clearances and approvals
Apple, Inc. has 9 FDA 510(k) clearances (first 2020, latest 2026), plus 3 De Novo decisions, across 7 product codes in 5 review panels. Median 510(k) review time: 135 days. Since 2017 its median was 135 days, against 146 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 6 device clinical trials on ClinicalTrials.gov. It files with the SEC as Apple Inc. (AAPL).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 122 |
| 2021 | 1 | 73 |
| 2022 | 1 | 165 |
| 2023 | 1 | 87 |
| 2024 | 2 | 130 |
| 2025 | 2 | 180 |
| 2026 | 1 | 135 |
Review time against the same product codes
Since 2017, Apple, Inc.'s cleared 510(k)s took a median 135 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 146 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QDB | Photoplethysmograph Analysis Software For Over-The-Counter Use | 4 | 3 |
| QDA | Electrocardiograph Software For Over-The-Counter Use | 2 | 1 |
| SCW | Digital Prismatic Correction | 2 | 2 |
| QZW | Over-The-Counter Device To Assess Risk Of Sleep Apnea | 1 | 1 |
| SCR | Air-Conduction Hearing Aid Software | 1 | 0 |
| SFR | Hypertension Machine Learning-Based Notification Software | 1 | 1 |
| SHN | Calibration Software For Radiology Displays | 1 | 1 |
Review panels
- Cardiovascular (7)
- Ophthalmic (2)
- Anesthesiology (1)
- Ear, Nose and Throat (1)
- Radiology (1)
Most recent Apple, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253582 | Medical Imaging Calibration Feature (MICF) | SHN | 2026-04-01 | 135 |
| K250507 | Hypertension Notification Feature (HTNF) | SFR | 2025-09-11 | 202 |
| K250143 | Digital Prism Correction Feature (DPCF) | SCW | 2025-06-23 | 157 |
| K242058 | Digital Prism Correction Feature (DPCF) | SCW | 2024-10-21 | 98 |
| K240929 | Sleep Apnea Notification Feature (SANF) | QZW | 2024-09-13 | 162 |
| K231173 | Irregular Rhythm Notification Feature (IRNF) | QDB | 2023-07-21 | 87 |
| K213971 | Atrial Fibrillation History Feature | QDB | 2022-06-03 | 165 |
| K212516 | IRNF App | QDB | 2021-10-22 | 73 |
| K201525 | ECG App | QDA | 2020-10-08 | 122 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230081 | De Novo | Air-Conduction Hearing Aid Software | 2024-09-12 |
| DEN180042 | De Novo | Photoplethysmograph Analysis Software For Over-The-Counter Use | 2018-09-11 |
| DEN180044 | De Novo | Electrocardiograph Software For Over-The-Counter Use | 2018-09-11 |
Recalls
openFDA lists no recalls under a recalling firm named Apple, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Apple, Inc. is the industry lead sponsor of 6 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05872035: Smartphone Enabled Hearing Study (Completed, started 2023-04-20)
- NCT04699812: Atrial Fibrillation Algorithms Clinical Validation Study (Completed, started 2020-11-16)
- NCT04247581: ECG App Algorithms Clinical Validation Study (Completed, started 2020-01-07)
- NCT03769207: Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias (Completed, started 2018-12-08)
- NCT03492554: Electrocardiogram Clinical Validation Study (Completed, started 2018-03-12)
SEC filings
Apple Inc. (AAPL): EDGAR filings, CIK 320193. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Apple, Inc. have?
Apple, Inc. has 9 FDA 510(k) clearances (first 2020, latest 2026), plus 3 De Novo decisions, across 7 product codes in 5 review panels.
How long does FDA take to clear Apple, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Apple, Inc.'s cleared 510(k)s is 135 days. Since 2017: 135 days, versus 146 days for all cleared 510(k)s in the same product codes.
What devices does Apple, Inc. make?
Its most frequent FDA product codes are QDB (Photoplethysmograph Analysis Software For Over-The-Counter Use, 4); QDA (Electrocardiograph Software For Over-The-Counter Use, 2); SCW (Digital Prismatic Correction, 2).
Has Apple, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Apple, Inc. Related entities may recall under other names.
Next steps
- See all 9 Apple, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QDB, Apple, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.