About one FDA 510(k) clearance in ten is now for a device on the AI list
Share of the 510(k) clearances the FDA decided each year that are on its list of AI-enabled devices, all review committees, the radiology committee and every other committee together, 2016 to June 2026
Show the numbers as a table
| Period | Radiology committee | All 510(k) clearances | Every other committee |
|---|---|---|---|
| 2016 | 2.6% | 0.6% | 0.3% |
| 2017 | 3.5% | 0.7% | 0.3% |
| 2018 | 9.1% | 1.9% | 0.8% |
| 2019 | 14.6% | 2.8% | 1.1% |
| 2020 | 23.8% | 3.9% | 0.6% |
| 2021 | 26.3% | 4.1% | 0.6% |
| 2022 | 32.9% | 5.0% | 0.8% |
| 2023 | 39.0% | 6.6% | 1.5% |
| 2024 | 43.6% | 7.3% | 1.7% |
| 2025 | 54.0% | 10.3% | 2.8% |
| Jan to Jun 2026 | 53.4% | 10.6% | 3.1% |
About the data
- Sources
- FDA, Artificial Intelligence-Enabled Medical Devices (opens in a new tab)The list (CSV), content current as of September 4, 2026: Date of Final Decision, Submission Number, Panel (Lead), Primary Product Code
- FDA, 510(k) releasable files (opens in a new tab)pmn96cur.txt (October 26, 2026): DATERECEIVED, DECISIONDATE, DECISION, REVIEWADVISECOMM, TYPE
- Method
- Kent Applied joined each device on the FDA's AI-Enabled Medical Device List (the version current as of September 4, 2026: 1,614 devices with final decisions from September 29, 1995, to June 29, 2026) to its record in the FDA's 510(k), PMA and product classification files by submission number. The FDA says the list is not a comprehensive resource of AI-enabled devices. A year's share is the AI-listed 510(k)s with decisions that year over every 510(k) in the FDA's releasable 510(k) file with a substantially equivalent decision that year. The committee is the review advisory committee in the 510(k) file. 2026 runs from January to June on both sides, because the list's last decision is June 29, 2026.
- Published
Free to share and embed with credit to Kent Applied (CC BY 4.0). The source data keeps its own terms.
Facts from this chart
54.0%
of the 510(k) clearances tagged with the FDA's radiology review committee in 2025 were for devices on its AI list
In 2025, 252 of the 467 510(k) clearances tagged with the FDA's radiology review committee (54.0%) were for devices on the FDA's AI-Enabled Medical Device List, by Kent Applied's count.
Source: FDA, Artificial Intelligence-Enabled Medical Devices.
KentApplied10.3%
of the FDA's 3,198 510(k) clearances in 2025 were for devices on its list of AI-enabled devices
In 2025, 329 of the 3,198 510(k) clearances in the FDA's 510(k) file (10.3%) were for devices on the FDA's AI-Enabled Medical Device List, by Kent Applied's count.
Source: FDA, Artificial Intelligence-Enabled Medical Devices.
KentApplied
Related charts
- From research
More than half of the FDA's 2025 clearances tagged radiology were for AI-listed devices
FDA, Artificial Intelligence-Enabled Medical Devices; FDA, 510(k) releasable files - From research
Three in four AI-listed devices are in the radiology panel; its share peaked in 2020
FDA, Artificial Intelligence-Enabled Medical Devices - From research
A quarter of the devices on the FDA's AI list are filed under scanner product codes
FDA, Artificial Intelligence-Enabled Medical Devices; FDA, product classification file - From research
40 devices on the FDA's AI list came through De Novo grants, each a new device type
FDA, Artificial Intelligence-Enabled Medical Devices; FDA, product classification file; FDA, De Novo Classification Request
Sources for the figures above: FDA, De Novo Classification Request (opens in a new tab).
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