Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wright Medical Corp. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K905129 | BAERVELDT GLAUCOMA IMPLANT | Wright Medical Corp. | 1991-02-11 | 89 | 0 |
| K901015 | WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC | Wright Medical Corp. | 1990-11-05 | 245 | 0 |
| K892501 | WRIGHT MEDICAL FETASAFE | Wright Medical Corp. | 1989-09-12 | 160 | 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