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How long will it take my 510(k) to be cleared by the US FDA?

Use the calculator below to see how many calendar days it has historically taken for the US Food and Drug Administration to clear other medical devices with the same Product Code. Don’t know your product code? Search the FDA Product Classification Database.

This calculator includes publicly available 510(k) data for devices cleared (not submitted) between January 1, 2012 through September 30, 2017. We update this data several times per year. The data includes Traditional submissions only and excludes 510(k) reviews done by Third Party Reviewers. Your device may take longer to clear than the historical average based on the quality of your submission, Additional Information requests from the FDA reviewer and how long you take to respond to those requests. Please use this information for planning purposes only. If you need assistance with complicated device classification issues or FDA 510(k) preparation, please let us know and we can provide a proposal.

All fields required. Valid years: 2012 to 2017. Enter year(s) in YYYY format.

Format: 2021
Format: 2021