Free AI research · FDA database evidenceFDA Predicate Device Finder & Regulatory Pathway Research Agent
Describe your medical device. The agent searches FDA classifications, 510(k) clearances, De Novo decisions, PMAs, and GUDID records, then explains likely product-code and pathway directions with source evidence.
Research your likely FDA pathway
Include the intended use, users, patient population, operating principle, patient contact, duration, software role, and whether the device is sterile, active, implantable, or measuring.
What the research agent searches
The agent searches FDA product classification records, releasable 510(k) clearances, De Novo decisions, PMA records, and GUDID device-identification records using a planned generic device term. Every cited record links to its official FDA source.
Results are preliminary database research, not an FDA classification, predicate determination, or legal opinion — a valid predicate still requires a documented substantial-equivalence comparison.
- Does this tool determine my FDA classification or pathway?
- No. It identifies evidence-supported possibilities and uncertainties. The final pathway depends on the complete intended use, technology, risk profile, and current FDA requirements.
- Are the suggested 510(k) records legally valid predicates?
- Not automatically. The agent only suggests retrieved records that may merit review. A predicate must be legally marketed and substantially equivalent in intended use and technological characteristics.
- Why might the tool return no predicate candidates?
- The retrieved 510(k) records may be too broad, technologically different, or based on insufficient product detail. An empty result is more useful than presenting a weak match as a predicate.
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