AI-listed 510(k)s took a median 141 days to a decision in 2025, against 126 for all
Median days from the FDA receiving a 510(k) to its clearance, all cleared 510(k)s and those on the FDA's list of AI-enabled devices, by year of decision, 2018 to 2025
Show the numbers as a table
| Category | All cleared 510(k)s | AI-listed 510(k)s |
|---|---|---|
| 2018 | 121 days | 109 days |
| 2019 | 118 days | 128 days |
| 2020 | 122 days | 140 days |
| 2021 | 135 days | 118 days |
| 2022 | 143 days | 121 days |
| 2023 | 135 days | 140 days |
| 2024 | 129 days | 147 days |
| 2025 | 126 days | 141 days |
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
- FDA, 510(k) Submission Process (opens in a new tab)Additional Information (AI) Request
- 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. Days run from the date the 510(k) file gives as received to its decision date. The span includes any days a submission was on hold while the company answered the FDA's requests for more information, so it is the total time to a decision, not the FDA's review time alone. The medians are over 58 (2018), 80 (2019), 113 (2020), 122 (2021), 160 (2022), 219 (2023), 225 (2024), 329 (2025) AI-listed 510(k)s.
- 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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