The FDA’s 510(k) premarket notification process plays a central role in U.S. medical device regulation. It enables companies to bring moderate-risk devices to market by proving they are “substantially equivalent” to already cleared devices.
Introduced in 1976 under the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act.
Unlike the more stringent Premarket Approval (PMA) process, 510(k) does not usually require new clinical trials. Instead, manufacturers must show their device has the same intended use and technological characteristics as a previously cleared device. If there are differences, they must not raise new questions of safety or effectiveness.
Substantial equivalence is the cornerstone of this pathway. A company identifies a predicate device, already on the U.S. market, and compares the new product to it. The predicate must be legally marketed, meaning it went through a 510(k), PMA, or was grandfathered in before 1976.
For example, a company producing a new digital thermometer might compare it to a similar thermometer cleared in 2010. If the new device measures temperature using the same principles and for the same use, the FDA may clear it through 510(k).
The process typically takes between 90 and 180 days. However, delays can occur if documentation is incomplete or comparisons are unclear. The FDA expects detailed technical descriptions, performance data, labeling, and a summary of differences from the predicate.
Most Class II devices, those with moderate risk, fall under 510(k). These include items like infusion pumps, glucose monitors, and surgical gloves. Class I devices (low risk) often don’t require 510(k), while Class III (high risk) go through PMA.
There are three types of 510(k) submissions.
- Traditional 510(k) is the most common and includes all required sections.
- Special 510(k) is used when a manufacturer modifies its own legally marketed device without changing intended use or technology.
- Abbreviated 510(k) relies on guidance documents or recognized standards to support substantial equivalence.
In 1998, the FDA launched the Special 510(k) program to speed up review for minor modifications. In 2019, it revised the guidance to clarify eligibility and streamline review.
More recently, in September 2023, the FDA introduced updates aimed at increasing transparency and improving predicate selection. Manufacturers are now encouraged to use newer predicates when possible. The goal is to avoid relying on outdated technology or devices that are no longer marketed.
This push addresses a long-standing criticism of the 510(k) system. Some experts argue that reliance on older predicates allows inferior devices to remain indirectly on the market. FDA’s update aims to reduce this risk by promoting modern standards and better evidence.
Another notable development involves the FDA’s “Safety and Performance Based Pathway,” announced in 2019. This is a voluntary option for devices where FDA has identified well-established performance criteria. Instead of comparing to a specific predicate, manufacturers can show their device meets FDA-defined standards. This supports more efficient reviews, especially for devices with minimal innovation but consistent safety profiles.
During the COVID-19 pandemic, the FDA used Emergency Use Authorizations (EUAs) for many devices. But for long-term clearance, many still had to go through the 510(k) route. This underscored the ongoing importance of the pathway.
In FY2022, the FDA received over 3,000 traditional 510(k) submissions. This confirms its role as the main regulatory route for most U.S. medical devices. Most submissions are from small to mid-size manufacturers, especially in diagnostics, digital health, and wearable tech.
However, global companies also rely on 510(k) to access the U.S. market. Because clearance is device-specific, not manufacturer-specific, multiple companies may have similar cleared products.
It’s important to note that 510(k) clearance is not FDA “approval.” It confirms equivalence, not superiority or innovation. Marketing materials must reflect this and avoid implying full FDA endorsement.
The process is evolving. Digital health tools and AI-powered devices challenge traditional review approaches. The FDA has begun adapting 510(k) criteria to address software, algorithm updates, and cybersecurity.
