Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Circle Rubber Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
103 daysmedian FDA review time
112 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K890407 | THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION | Circle Rubber Corp. | 1989-05-16 | 112 | 0 |
| K883467 | THE SAXON SPERMICIDAL CONDOM | Circle Rubber Corp. | 1988-10-26 | 75 | 0 |
| K872736 | PROPHYLACTIC (CONDOM) | Circle Rubber Corp. | 1987-10-20 | 103 | 0 |
| K842502 | WRINKLE CHAPEAU BLACKY | Circle Rubber Corp. | 1984-09-21 | 87 | 0 |
| K813172 | CONDOM-MULTIPAL STYLES | Circle Rubber Corp. | 1982-03-05 | 109 | 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