Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Unicare Biomedical, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
260 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151344 | Cytoflex Tefguard Ti-Enforced Membrane | Unicare Biomedical, Inc. | 2015-11-19 | 184 | 0 |
| K092567 | MODIFICATION TO UNIGRAFT | Unicare Biomedical, Inc. | 2009-11-25 | 97 | 0 |
| K090083 | CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 | Unicare Biomedical, Inc. | 2009-03-23 | 70 | 0 |
| K080532 | BENACEL, MODELS C-001, C-002 AND C-005 | Unicare Biomedical, Inc. | 2008-11-12 | 260 | 0 |
| K021511 | CYTOFLEX MESH | Unicare Biomedical, Inc. | 2002-08-06 | 89 | 0 |
| K020720 | OSSIFORM | Unicare Biomedical, Inc. | 2002-05-07 | 63 | 0 |
| K012144 | CYTOFLEX | Unicare Biomedical, Inc. | 2001-10-01 | 83 | 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