What is FDA 510(k) clearance?
FDA 510(k) clearance is a US pathway that lets a medical device go on sale. The Food and Drug Administration must first agree it is substantially equivalent to a device already legally marketed. Most AI-enabled medical devices have used this route.
Also known as: 510(k), premarket notification, FDA clearance
Researched and fact-checked by AI, with no human review. 7 sources listed below. How we verify
Last updated
How it works
The name comes from section 510(k) of the Federal Food, Drug, and Cosmetic Act. The section requires device manufacturers to notify the Food and Drug Administration (FDA) at least 90 days before marketing a device. The filing is known as a premarket notification.
In it, the FDA explains, a company compares its product with a predicate, a device already legally on the US market. The FDA says the company argues the two are substantially equivalent. That requires the same intended use and either the same technological characteristics or differences that raise no different questions of safety and effectiveness. Supporting evidence can include bench testing, software validation and clinical data. If the agency agrees, it issues a letter that clears the device for sale. It says that decision usually comes within 90 days.
The FDA sorts devices into three classes by risk. Class I and II devices that are not exempt need a 510(k). Class III devices, the highest-risk group, generally require a premarket approval (PMA) application instead. In FDA usage a 510(k) device is cleared, while approval belongs to the PMA route.
Why it matters for AI in 2026
The FDA says it regulates medical devices, including those that use AI, not AI itself. It says it had authorized more than 1,600 AI-enabled devices as of September 2026. A 2026 analysis in the Journal of Medical Internet Research studied the agency's list. It found that 1,376 of the 1,430 AI-enabled devices with final decisions through 2025, or 96.2%, came through the 510(k) pathway.
Because each clearance leans on an earlier product, devices form chains of predicates. A 2023 analysis in The Lancet Digital Health covered 285 AI devices cleared from 2019 to 2021. It reported that 93, about a third, were cleared on the basis of non-AI predicates in the first generation, with another 23 unclear. Its authors urged more attention to AI's distinctive characteristics when equivalence is judged.
Updates after clearance
The FDA says a modification that could significantly affect a cleared device's safety or effectiveness requires a new 510(k). Final guidance dated August 2025 sets out recommendations for predetermined change control plans. These describe planned modifications to an AI-enabled device and how they will be developed, validated and implemented. The FDA reviews a plan as part of a marketing submission. So the modifications it covers do not each need a further one.
Sources
- Premarket Notification 510(k), U.S. Food and Drug Administration
- 510(k) Clearances, U.S. Food and Drug Administration
- Classify Your Medical Device, U.S. Food and Drug Administration
- Artificial Intelligence-Enabled Medical Devices, U.S. Food and Drug Administration
- Clinical Specialty Expansion of AI-Enabled and Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration From 1995 to 2025: Longitudinal Content Analysis, Journal of Medical Internet Research, via PubMed Central (US National Library of Medicine)
- FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks, The Lancet Digital Health, Internet Archive capture of 29 July 2024
- Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions, U.S. Food and Drug Administration
