Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Unicare Biomedical — 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) |
|---|---|---|---|---|---|
| K090612 | BENACEL | Unicare Biomedical | 2009-07-24 | 140 | 0 |
| K003457 | UNIGRAFT | Unicare Biomedical | 2001-01-09 | 63 | 0 |
| K993784 | UNIGRAFT | Unicare Biomedical | 2000-01-27 | 80 | 0 |
| K982699 | UNIGRAFE | Unicare Biomedical | 1998-10-20 | 78 | 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