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Enter a device name or description to search FDA's product classification database. Results show the product code, device class, regulation number, and likely submission pathway. All results are informational — classification for your specific device depends on intended use and design.
Searches openFDA's device classification database · Results are informational
Classification Fundamentals
FDA assigns every cleared or classified medical device type a three-letter product code drawn from its 21 CFR Parts 862–892 classification regulations. The code determines your device class (I, II, or III), the specific regulation section that governs it, and the required premarket pathway — 510(k), De Novo, PMA, or exempt from premarket notification. The same product code often applies to a broad device category, but whether your specific device fits that code depends on its intended use, technology, and design features. Getting the product code right is the first regulatory question for any medical device entering the US market.
Common Questions
FDA product codes are three-letter identifiers assigned to each device type in FDA's 21 CFR Parts 862–892 classification regulations. Each code corresponds to a specific device type, device class (I, II, or III), regulation number, and required submission pathway. The product code determines whether your device requires a 510(k), De Novo, PMA, or is exempt from premarket notification.
Start with this free tool — enter a device name or technology description to search FDA's product classification database. The tool searches openFDA and returns matching product codes with device class and regulation information. Because product codes are assigned at the device-type level, the correct code for your specific device depends on its intended use and design — use these results as a starting point, not a final determination.
Not necessarily. A product code identifies the device type that FDA classified — your device may share characteristics with a Class II product code but differ in ways that affect classification. Device class depends on your specific intended use, design features, and applicable special controls. ADB's Classification Determination Memo reviews your specific device against the product code, regulation, and applicable special controls and delivers a written determination.
No match in FDA's classification database is a meaningful signal — it may indicate a novel device type not yet classified by FDA, a combination product, or a device that may qualify for a De Novo pathway rather than 510(k). A Classification Determination Memo identifies the appropriate regulatory pathway when no predicate product code clearly applies to your device's intended use and technology.
Ready for a Written Determination?
A product code identifies the device type. A Classification Determination Memo identifies the correct code, class, and pathway for your specific device — in writing, in days, at a flat fee.