Find your predicate.
Or your competition.
Or both.
Deep 510(k) database search with AI-powered similarity scoring. Comparison tables, equivalence analysis, De Novo precedents, and full competitive landscape — in a single research session.
Research that goes as deep as you need.
Predicate selection
AI-ranked shortlist of cleared 510(k)s with similarity scoring across intended use, technology, indications, and patient population.
De Novo precedent search
Find De Novo decisions for novel device types — see how FDA evaluated similar devices, what special controls were imposed, and what safety studies were required.
Market landscape
See all cleared devices in your category, their clearance dates, applicants, and predicate chains. Know the competitive context before you submit.
PMA precedent research
For Class III devices — find PMA approvals in your device category, review panel decisions, conditions of approval, and post-approval study requirements.
Predicate risk history
Pull MAUDE adverse events and recalls for your predicate devices. Know the failure modes FDA has seen before you claim substantial equivalence.
Export-ready comparison tables
Side-by-side comparison tables formatted for Section 5 of your 510(k) — intended use, technology, performance, and substantial equivalence justification.
Comparison tables, ready for Section 5.
Every predicate research session ends with an export-ready comparison table. Drop it straight into your Submission Builder or Drafting Studio.
- Side-by-side intended use comparison
- Technological characteristics with SE justification
- Performance data from the predicate’s 510(k) summary
- Equivalence score with AI-generated justification draft