Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rfsu — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
148 daysmedian FDA review time
171 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K902907 | MAMBA CONDOM (RUBBER LATEX) | Rfsu | 1990-12-21 | 171 | 0 |
| K894533 | CONDOM (RUBBER LATEX) KILROY | Rfsu | 1989-12-18 | 152 | 0 |
| K894534 | CONDOM (RUBBER LATEX) OKEIDO | Rfsu | 1989-12-14 | 148 | 0 |
| K895894 | PROFIL CONDOM (RUBBER LATEX) | Rfsu | 1989-12-14 | 70 | 0 |
| K895028 | BIRDS'N BEES CONDOMS | Rfsu | 1989-12-14 | 128 | 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