510(k)
Premarket Notification 510(k) · 510k · premarket notification
The FDA pathway to market for most moderate-risk medical devices — demonstrate substantial equivalence to a legally-marketed predicate device. ~3,000 clearances per year.
Under Section 510(k) of the FD&C Act, most Class II devices (and a few Class I and Class III) reach the US market by demonstrating Substantial Equivalence to a predicate device — same intended use, same technological characteristics, or different technological characteristics that don't raise different questions of safety and effectiveness.
A 510(k) submission includes device description, indications for use, comparison to predicate, performance testing (bench, animal, clinical where required), labelling, biocompatibility, software documentation, sterilisation validation. Median FDA review ≈ 4–6 months.
V5's DHF module assembles 510(k)-ready evidence: design inputs, V&V protocols and reports, risk management file, software lifecycle artefacts, and labels — all from the live records, no last-minute scramble.
- 21 CFR 807 Subpart E
Free trial, no credit card, onboard in days, not months.