Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mentor Corporation · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062421 | MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER | Mentor Corporation | 2006-10-10 | 53 | 1 |
| K053296 | MENTOR ARIS SUPRAPUBIC SURGICAL KIT | Mentor Corporation | 2005-12-15 | 20 | 0 |
| K052440 | MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER | Mentor Corporation | 2005-10-11 | 35 | 0 |
| K050148 | MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT | Mentor Corporation | 2005-03-09 | 44 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda