Short answer: FDA's AI-enabled medical device list contains 1,614 devices (decisions through Jun 29, 2026). 76.2% were reviewed by the radiology panel, 96.2% were cleared through 510(k), and 2025 was the record year with 335 decisions.
Every number on this page is computed from our copy of FDA's AI-enabled device list joined to openFDA, and is recalculated each time the data is rebuilt. See the methodology for what the list does and doesn't cover. Data is free to reuse under CC BY 4.0: devices.json.
By pathway
| Pathway | Devices | Share | Median review (calendar days) |
|---|---|---|---|
| 510(k) | 1,553 | 96.2% | 136 |
| De Novo | 40 | 2.5% | 288 |
| PMA | 17 | 1.1% | 355 |
| PMA supplement | 4 | 0.2% | 118 |
By specialty (review panel)
| Panel | Devices | Share |
|---|---|---|
| Radiology | 1,230 | 76.2% |
| Cardiovascular | 154 | 9.5% |
| Neurology | 73 | 4.5% |
| Anesthesiology | 30 | 1.9% |
| Gastroenterology-Urology | 27 | 1.7% |
| Hematology | 22 | 1.4% |
| Pathology | 10 | 0.6% |
| Ophthalmic | 10 | 0.6% |
| General and Plastic Surgery | 9 | 0.6% |
| Clinical Chemistry | 9 | 0.6% |
| Orthopedic | 8 | 0.5% |
| Dental | 7 | 0.4% |
| Microbiology | 7 | 0.4% |
| General Hospital | 6 | 0.4% |
| Obstetrics and Gynecology | 5 | 0.3% |
| Clinical Toxicology | 5 | 0.3% |
| Ear Nose & Throat | 1 | 0.1% |
| Immunology | 1 | 0.1% |
By decision year
| Year | Devices |
|---|---|
| 2026 (through Jun 29) | 181 |
| 2025 | 335 |
| 2024 | 235 |
| 2023 | 226 |
| 2022 | 162 |
| 2021 | 129 |
| 2020 | 114 |
| 2019 | 80 |
| 2018 | 65 |
| 2017 | 27 |
| 2016 | 18 |
| 2015 | 6 |
| Before 2015 | 36 |
By applicant country (top 10)
| Country | Devices | Share |
|---|---|---|
| United States | 738 | 45.7% |
| Israel | 125 | 7.7% |
| France | 96 | 5.9% |
| China | 85 | 5.3% |
| South Korea | 81 | 5.0% |
| Japan | 63 | 3.9% |
| Canada | 59 | 3.7% |
| United Kingdom | 50 | 3.1% |
| Netherlands | 43 | 2.7% |
| Germany | 33 | 2.0% |
Source: FDA, Artificial Intelligence-Enabled Medical Devices list, joined to openFDA 510(k), De Novo and PMA records. Review time is in calendar days from openFDA records, not FDA's review clock. FDA notes its list is not comprehensive.
FAQ
How many AI medical devices has FDA authorized?
FDA's AI-enabled medical device list contains 1,614 devices with decisions through Jun 29, 2026. FDA says the list is not a comprehensive resource.
Which specialty has the most FDA-listed AI devices?
Radiology, with 1,230 devices (76.2% of the list).
How long does FDA review take for AI devices?
The median review time is 136 calendar days for 510(k) clearances and 288 for De Novo grants on the list.