What is an FDA medical device product code?
It is a three-character identifier for a generic device category. FDA classification records connect the code to a device name, class, regulation, specialty, and expected submission type.
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FDA Product Code Lookup & Classification Database
Find the FDA generic device type, three-character product code, regulatory class, 21 CFR regulation, submission type, specialty, and key exemption flags for a medical device category.
Direct FDA source dataFree, no account requiredOfficial record links
Find the generic device type
Search FDA classification names and definitions rather than guessing from a brand name.
Check class and pathway direction
Review the class, submission type, regulation, and exemption indicators tied to the product code.
Continue into FDA records
Use the code to search related 510(k), PMA, De Novo, GUDID, MAUDE, and recall records.
Search FDA product classifications
Look up a product code by generic device name, known code, regulation number, or medical specialty.
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Important interpretation note
This lookup reproduces public FDA classification data. Selecting the correct product code and regulatory pathway requires a complete review of intended use, technology, risks, and current FDA policy.
How to use an FDA product code result
FDA product codes identify generic device categories. Match the official device definition and intended use—not only a similar product name—before treating a code as relevant.
The listed class and submission type describe the classification record. A device may still require a different pathway when its intended use, technology, risks, combination-product status, or applicable policy differs.
Use the product code as a starting point for reviewing the regulation, special controls, recognized standards, cleared or approved devices, recalls, and post-market reports.
Frequently asked questions
Can I determine a product code from a brand name alone?
Usually not reliably. Product-code selection depends on the generic device type, intended use, technology, and the definition in the applicable classification record.
Does a product code prove that my device is 510(k) exempt?
No. The classification record is an important starting point, but exemption limitations, device-specific characteristics, and current FDA requirements must also be reviewed.
How often is the classification data updated?
FDA states that the openFDA Device Classification endpoint is updated monthly. The result header shows the dataset update date when available.