1
Understand the device
The agent extracts a generic product identity and characteristics from your complete description.
Free AI research · FDA database evidence · No signup
FDA 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.
Plan the right search
Turn a product description into a concise FDA device-category search.
Search five evidence branches
Compare classifications, 510(k)s, De Novos, PMAs, and GUDID products.
Explain agreement and uncertainty
See likely directions, possible predicates, alternatives, and missing facts.
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.
Try an example:
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
How the FDA research agent works
2
Retrieve FDA records
It searches current official machine-readable datasets without vector embeddings or a hidden local document copy.
3
Synthesize with constraints
The model can cite only retrieved K numbers and must state uncertainty when the evidence does not support a pathway.
FDA predicate and pathway FAQ
What does the FDA research agent search?
It 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.
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.