Search 510(k) clearances to identify potential predicate devices
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Tip: Search by device function (e.g. "glucose monitoring" or "surgical stapler").
Product Code is key for predicates — devices with the same code share intended use.
FDA Product Classification Database
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K-Number
Device Name
Applicant
Code
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This tool is provided for informational purposes only and does not constitute regulatory, legal, or professional advice.
The 510(k) data is sourced from the FDA's openFDA API and may not reflect the most current information.
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Users are responsible for independently verifying all information with official FDA sources before making regulatory decisions.
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