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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.

Find the generic device typeCheck class and pathway directionContinue into FDA recordsopenFDA Device Classification API

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Look up a product code by generic device name, known code, regulation number, or medical specialty.

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About the data

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.

Read the official FDA dataset documentation

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.
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.

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