How to find a predicate device

What a predicate has to be

A legally marketed device that a new device is compared with in a 510(k) to show substantial equivalence: the same intended use, and either the same technological characteristics or different ones that raise no different questions of safety and effectiveness. The choice shapes the whole submission: the testing you run, the comparison table, and how long review takes.

1. Find the product code

Search FDA's classification by device name, or find a device like yours and read its product code from its 510(k). The product code index lists the codes with the most 510(k) history, each with its class, regulation and review times.

2. List the 510(k)s cleared under that code

In PredicateScope, search by the product code to see every clearance under it, newest first, with applicants, decision dates, review times and links to the summary PDFs. Recent clearances are usually the better candidates: they were reviewed against current expectations and current recognized standards.

3. Shortlist on intended use, then technology

Intended use has to match. Then compare technological characteristics: design, materials, energy source, software. Differences are allowed if they raise no different questions of safety and effectiveness, but each one has to be addressed with data. A predicate that needs fewer explanations makes a simpler submission.

4. Read the 510(k) summaries

In its 510(k) summary, which names the predicate in the substantial-equivalence discussion. Not every clearance has one: as of 2026-08-17, 93,524 of 175,879 510(k) records (53%) had a summary; 25,973 (15%) had only a statement, which names no predicate, and the rest had neither marked. The summary also shows how the predicate was tested, which is a strong hint at what FDA will expect from you.

5. Check the candidate's safety record

FDA's draft guidance on predicate selection (Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission) encourages choosing predicates cleared using well-established methods, that meet or exceed expected safety and performance, that have no unmitigated use-related or design-related safety issues, and that have no associated design-related recall. Check recalls and adverse event reports for each candidate: how to search MAUDE explains how.

6. Plan the timeline

A Traditional 510(k) took a median of 148 calendar days from FDA receipt to clearance across 22,438 clearances (2018–2026). See 510(k) review times for every type and year, and the product code pages for your device type.