FDA 510(k) Device Pathway

flowchart LR
Idea[New device concept] --> Class{Device class}
Class -->|Class I| Exempt[Mostly 510k exempt]
Class -->|Class II| Pred[Identify predicate]
Class -->|Class III| PMA[Premarket Approval]
Pred --> Tests[Bench + biocompat + electrical testing]
Tests --> Sub["510(k) submission"]
Sub --> Rev["FDA review (~3-6 mo)"]
Rev --> Dec{Substantially equivalent?}
Dec -- yes --> Clear[Cleared to market]
Dec -- no --> NSE[NSE → de novo or PMA route]
Clear --> Surv[Post-market surveillance]