510(k) Review Time Analyzer
Analyze FDA 510(k) clearance timelines by product code. See how long the FDA takes to review submissions, track approval rates, and explore historical trends.
Average review time by year
DaysReview time distribution
DaysTop advisory committees by volume
Understanding 510(k) review times
The FDA's 510(k) review process typically takes between 90 and 150 days from the date a submission is received to a final decision. However, actual timelines vary significantly depending on the device type, complexity of the submission, and whether the FDA requests additional information.
The review time shown here is calculated as the number of calendar days between the FDA's received date and the decision date. This includes any time spent in FDA review holds or additional information requests. The FDA's performance goal for 510(k) reviews is 90 days, but this refers to FDA review days (excluding time waiting for applicant responses).
Product codes with higher device classifications (Class II vs. Class I) tend to have longer review times due to more stringent regulatory requirements. Use the search above to explore review timelines for specific device categories.