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Predicate prep/US
Predicate device search: 3 steps before calling a consultant
Use FDA 510(k), product-code, and similar-device clues to prepare a better consultant call before spending paid review time.
Direct answer
A predicate search is not just typing your product name into FDA's 510(k) database. Start with intended use and product-code clues, then look for similar devices, cleared indications, technological characteristics, and differences that may matter.
The goal before a consultant call is not to prove your predicate. It is to bring a clean shortlist, links, and questions so the expert review starts at a higher level.
Use this if
Reader
A founder preparing for a 510(k) consultant conversation
Trigger
The team wants to avoid spending the first paid call on basic database searching
Blocked decision
Which similar devices, product codes, and claim boundaries deserve review
Useful output
A source-linked starter shortlist for qualified review
Do these first
- Search by product code, device type, company, and core technology.
- Capture 510(k) numbers, product codes, decision dates, and indications.
- Write why each candidate is similar and where it is different.
- Flag claim, technology, software, patient population, and setting differences.
What to collect before you ask for help
- Candidate 510(k) records and summaries.
- Product code and regulation number clues.
- Competitor labeling and public product pages.
- Your product's intended use and technology differences.
Common mistakes
- Picking the first similar-looking product as the predicate.
- Ignoring differences in intended use or technology.
- Sending a consultant a raw spreadsheet with no questions.
Public sources to start with