The FDA listed 335 AI-enabled devices with 2025 decisions, up from 18 in 2016
Devices on the FDA's AI-Enabled Medical Device List, counted by the year the FDA cleared, granted or approved them, 2010 to 2025. The yearly count more than doubled from 2022 (162) to 2025 (335).
Show the numbers as a table
| Period | Value |
|---|---|
| 2010 | 2 |
| 2011 | 3 |
| 2012 | 5 |
| 2013 | 4 |
| 2014 | 6 |
| 2015 | 6 |
| 2016 | 18 |
| 2017 | 27 |
| 2018 | 65 |
| 2019 | 80 |
| 2020 | 114 |
| 2021 | 129 |
| 2022 | 162 |
| 2023 | 226 |
| 2024 | 235 |
| 2025 | 335 |
About the data
- Source
- 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
- 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. The list also holds 181 devices with decisions from January to June 2026 and 16 from 1995 to 2009, which the chart leaves out.
- Published
Free to share and embed with credit to Kent Applied (CC BY 4.0). The source data keeps its own terms.
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).
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