Question 1

What is a predicate device?

Accepted Answer

A predicate device is a legally marketed medical device that a new 510(k) submission uses to demonstrate substantial equivalence. To clear a 510(k), you show FDA that your device has the same intended use and the same technological characteristics as the predicate (or that any differences do not raise new questions of safety and effectiveness). Choosing a strong, defensible predicate is one of the most important early decisions in a 510(k) strategy.

Question 2

How do I find a predicate device for my 510(k)?

Accepted Answer

Start from the FDA product code that appears to match your device classification, but treat product-code results only as a screening cohort. Search by device name, open potentially relevant clearances, and compare intended use, technological characteristics, labeling, and performance evidence. Confirm that any proposed predicate remains legally marketed before relying on it.

Question 3

What is an FDA product code and why does it matter for predicates?

Accepted Answer

A product code is a three-letter FDA classification tied to a device category, regulation number, and class. Filtering by product code is a useful way to assemble a screening cohort, but code overlap alone does not establish the same intended use, technological characteristics, legal-marketing status, or predicate eligibility.

Question 4

Is this FDA 510(k) database free to use?

Accepted Answer

Yes. The 510(k) predicate finder is free and requires no account. It searches the public FDA 510(k) clearance record so device and regulatory teams can scope predicates without a paid database subscription.

Question 5

Where does this 510(k) data come from?

Accepted Answer

The data comes from FDA's official releasable 510(k) downloadable files covering 1976 to the present. Each result links back to the authoritative Premarket Notification record on FDA.gov so you can verify the clearance details, summary, and decision directly at the source.

Question 6

How current is the 510(k) clearance data?

Accepted Answer

The committed FDA snapshot is current through July 26, 2026 and contains 175,204 substantially equivalent clearances. FDA says its downloadable files are replaced monthly, usually around the fifth day of the month; follow the FDA.gov link on any result to confirm a specific record.

Question 7

Can a recently cleared device be used as a predicate?

Accepted Answer

There is no recency requirement for a predicate, but the predicate must be legally marketed and should not have been removed from the market for reasons of safety or effectiveness. Many teams prefer a more recent predicate because its technology and labeling are closer to current expectations, which can simplify the substantial-equivalence argument. Always confirm the predicate's current status before building a submission around it.

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