FDA device classification and 510(k) predicate search — in seconds.
Describe your device and get its likely FDA device class, candidate FDA product codes, the probable premarket pathway (510(k), De Novo, PMA or exempt), real 510(k) predicate candidates with K-numbers, and high-level EU MDR and UK (UKCA / MHRA) considerations. Built for medical device start-ups, digital health and Software as a Medical Device (SaMD) teams, and small-to-mid-size medtech manufacturers.
Scope class, product code and pathway before a Pre-Sub, and shortlist predicates for your 510(k) strategy.
Check whether your software is a regulated device, and how FDA, MDR Rule 11 and UK rules would classify it.
Triage portfolio extensions and new markets — US clearance, CE marking under EU MDR, and UKCA in one view.
Informational only — not legal or regulatory advice. Results are AI-generated and may be incomplete or incorrect. Always confirm classification, product codes, and pathway with the FDA, the relevant EU Notified Body / MHRA, and qualified regulatory counsel.
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Device classification, product codes, and 510(k) predicates — explained
These answers are general educational context, not legal or regulatory advice. Run an analysis above for device-specific guidance.