Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Unidus Corp. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
90 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K072747 | UNIDUS MAGNUM MALE LATEX CONDOM | Unidus Corp. | 2007-11-15 | 49 | 0 |
| K033541 | LONG LOVE CONDOM | Unidus Corp. | 2003-12-23 | 43 | 0 |
| K023129 | UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK) | Unidus Corp. | 2002-12-13 | 85 | 0 |
| K023175 | UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING) | Unidus Corp. | 2002-12-13 | 81 | 0 |
| K023176 | UNDUS MALE LATEX CONDOM (WITH FLAVORING) | Unidus Corp. | 2002-12-13 | 81 | 0 |
| K023059 | UNIDUS MALE LATEX CONDOM | Unidus Corp. | 2002-12-12 | 90 | 0 |
| K891854 | SKIN ANGEL BRAND (PATIENT EXAM GLOVES - LATEX) | Unidus Corp. | 1989-04-11 | 15 | 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