United States · Food and Drug Administration · Medical devices
Review target
90 days
performance goal
Legal time limit
-
Not published
Steps
5
6 requirements
Application fee
$28,653
FY2027
The maker shows that the device is substantially equivalent to a device already legally sold in the United States (the predicate). The notification is sent at least 90 days before the device is put on the market. It is used for devices that are not exempt and do not need premarket approval. Class II devices and Class I devices that are not exempt, when a suitable predicate exists.
The official review target is 90 days (performance goal, met in 95% of cases). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The 510(k) premarket notification fee is $28,653 for FY2027. A reduced fee of $7,163 applies in some cases (Small businesses with gross receipts or sales of no more than 100 million dollars pay the reduced fee).
1. Send the 510(k) in eSTAR; 2. Acceptance review (15 days); 3. Substantive review (60 days); 4. Questions to the maker (clock stopped); 5. Decision.
Outcome: An order that the device is substantially equivalent (clearance), or not substantially equivalent.
Legal basis: Section 510(k) of the Federal Food, Drug, and Cosmetic Act; 21 CFR Part 807 Subpart E
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 75 days end to end with the official step targets. Targets, not actual times.
From the official approvals data of this market, all products of this pathway type and segment
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetperformance goal, met in 95% of cases. 90 review days for 95 percent of submissions. Review days count only the days the file is under agency review. This is an official target, not an actual review time. | 90 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| 510(k) premarket notification feeApplication · FY2027 · Small businesses with gross receipts or sales of no more than 100 million dollars pay the reduced fee. | $28,653reduced $7,163 |
Other routes in United States: Combination product: request for designation, De Novo classification request, Premarket approval (PMA), Humanitarian device exemption, Class I devices exempt from premarket notification, Software as a medical device: how it is regulated, Breakthrough devices program, Emergency use authorization. See all routes on the United States page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (14 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.