How to find a predicate device for a 510(k)

A predicate device is an earlier legally marketed device you claim substantial equivalence to. Finding one is a three-step job: narrow to your product code, read 510(k) summaries for the listed predicate, and keep watching the code while you draft. Here is each step, with a worked example.

Step 1: narrow to your product code

Start with earlier clearances in the same three-letter FDA product code. Our 510(k) index holds 176,140 clearance records, so almost every code has a pool worth searching. Review times differ by code, which sets your planning horizon: over the trailing 24 months to September 2026, LLZ ran a median 150 days (90th percentile 256, from 113 decisions), GEI a median 135 days, and GEX a median 90 days. Codes with fewer than 10 trailing decisions carry no benchmark, and we say so instead of inventing one.

Step 2: read the summary, not the listing

A same-code clearance is only a candidate until its 510(k) summary names a predicate. Summaries state the relationship with phrasings like "predicate device", "reference device", or a "510(k) number" column next to the predicate name. Our pipeline reads those citations the same way: for example, the summary for K201234 cites K042934 as a reference device, so K042934 is recorded as a cited predicate for K201234 and nothing else is inferred. Predicate citation is a stated equivalence claim in a summary, nothing more.

Worked example: product code LLZ (radiology imaging software)

LLZ has 2,287 clearances on file, led by Siemens Medical Solutions USA (74), Totoku Electric (40), and Barco (37). Recent clearances to investigate as predicates:

• K262060, cleared 2026-09-04: 3D-RD-S, Radiopharmaceutical Imaging and Dosimetry.
• K261500, cleared 2026-08-17: KBA3D (v2.4.0), S.M.A.I.O.
• K262449, cleared 2026-08-14: AdvaView, ADVAHEALTH SOLUTIONS, LLC.
• K261916, cleared 2026-08-12: NeuroQuant PET, Cortechs Labs, Inc.
• K260936, cleared 2026-07-31: RadioViewAI, Neurocareai, Inc.

For laser systems see the GEX predicate guide; for electrosurgical devices see the GEI predicate guide.

Step 3: watch the code while you draft

Predicate ground shifts: new clearances enter your code and old predicates get recalled. Run your number through the free medical device predicate search to see same-code candidates plus recalls in the code, check any product code for the latest clearances, and read how competitive intelligence works if you want it watched daily.

Data: U.S. FDA via openFDA (public domain), plus our 510(k) index of 176,140 records and review benchmarks computed September 2026. Not regulatory advice. Assume all results are unvalidated.