ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
Comparison between 510k medical device and De Novo medical device12,13)
510k | De Novo | |
---|---|---|
Predicate device | ○ | × |
Risk and effectiveness | be found in the approval document of predicate device | must be proved by applicant |
Risk class | 2 | 2 |
Approval process | Only 510k submission | (1) 510k decline (2) Direct De Novo |
Approval code form | KXXZZZZ | DENXXZZZZ |
Example | reSET-O® (K173681) | reSET® (DEN160018) |
reSET® is predicate device of reSET-O®.
XX=year of submission (e.g., 17=2017)
ZZZZ=submission increments from 0001