FDA Medical Device Product Code Lookup: Find Class, Regulation, and Pathway

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FDA Product Code Lookup

Find device classes, product codes, regulation numbers, and premarket pathways

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Use the product code lookup for a specific FDA task

An FDA medical device product code is a three-letter classification code connected to a device type, class, regulation citation, and review pathway. The FDA Product Code Lookup lets you search those fields directly. It is designed for medical device classification research; it is not a clone of the separate FDA import Product Code Builder.

Open the lookup above and search by product code when you know it, or by a precise device description when you do not.

What the result fields tell you

Treat the row as a research result, not as a final classification decision for an undescribed product. The intended use, technology, mode of action, anatomy, duration, and risk characteristics still matter.

Search by function, then narrow by technology

A marketing name is often a weak search term. Begin with what the device does and then add the technology or clinical setting. Compare several plausible rows instead of choosing the first one that shares a noun with the product.

For example, two devices may both be described as monitors while measuring different parameters, using different sensing methods, or serving different patient populations. Those differences can point to different product codes. Open the likely rows and compare their classification names and regulation references against the actual product profile.

Continue into connected FDA evidence

Once you have a candidate product code, open FDA TPLC Intelligence. It uses the product code as a connection point across classification, premarket, listing, recall, MAUDE, and GUDID records. This is useful when the question moves from “what code might fit?” to “what has FDA cleared, listed, recalled, or received reports about in this category?”

For a more open-ended question, use the FDA Predicate & Pathway Agent. Give it the product description and candidate codes, and ask it to compare pathway and predicate directions with citations. The tool should expose its evidence and uncertainty instead of silently selecting a code.

Avoid three common lookup mistakes

1. Searching only the commercial product name. FDA classification names are usually functional or technical.
2. Treating a code as proof of substantial equivalence. A shared product code is a useful search constraint, not a complete predicate comparison.
3. Confusing device product codes with import product codes. The same search phrase is used for different FDA tasks; this page is specifically about medical device classification codes.

A quick quality check

Before carrying a candidate code into another tool, confirm that:

• the classification name describes the same device function;
• the class and regulation number are internally consistent;
• the pathway shown fits the classification record;
• important differences in intended use or technology are still visible;
• related FDA records actually use the candidate code;
• the conclusion is phrased as a candidate when product facts remain unresolved.

The lookup saves time because it starts with the structured classification data users are actually trying to find. The connected tools then let you test that candidate against real FDA market and safety records.