Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Catalina Biomedical Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
92 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K920050 | BIOLEX WOUND GEL, | Catalina Biomedical Corp. | 1992-04-07 | 92 | 0 |
| K913480 | WOUND CARE TRAY A | Catalina Biomedical Corp. | 1991-10-18 | 73 | 0 |
| K913479 | WOUND CARE TRAY B | Catalina Biomedical Corp. | 1991-10-08 | 63 | 0 |
| K896358 | VARI/MOIST WOUND DRESSING | Catalina Biomedical Corp. | 1990-02-01 | 87 | 0 |
| K896421 | TRANSPARENT FILM I.V. SITE/WOUND DRESSING | Catalina Biomedical Corp. | 1990-01-31 | 84 | 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