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.
10.3%
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.
In 2016 it was 17 of 2,930 (0.6%). The list is the version current as of September 4, 2026.
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, COUNTRY_CODE. Verified October 2026.
Related charts
- From research
About one FDA 510(k) clearance in ten is now for a device on the AI list
FDA, Artificial Intelligence-Enabled Medical Devices; FDA, 510(k) releasable files - 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
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).
Related facts
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.
KentApplied141 days
median from the FDA receiving a 510(k) to its decision, for AI-listed 510(k)s decided in 2025
For the 510(k)s on the FDA's AI-Enabled Medical Device List decided in 2025, the median time from the FDA receiving the submission to its decision was 141 days, against 126 days for all 510(k)s cleared that year, by Kent Applied's count.
Source: FDA, Artificial Intelligence-Enabled Medical Devices.
KentApplied76.2%
of the 1,614 devices on the FDA's AI-Enabled Medical Device List are listed under its radiology panel
Radiology is the lead panel for 1,230 of the 1,614 devices on the FDA's AI-Enabled Medical Device List (76.2%), in the version current as of September 4, 2026, by Kent Applied's count.
Source: FDA, Artificial Intelligence-Enabled Medical Devices.
KentApplied
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