Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Safetex Corp. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
467 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K922889 | CONDOOM SHELF LIFE -- MODIFICATIONS | Safetex Corp. | 1993-09-01 | 467 | 0 |
| K910550 | CONDOMS/SAXON, GOLD CIRCLE COIN, EMBRACE & RAINBOW | Safetex Corp. | 1991-06-03 | 116 | 0 |
| K902509 | SAXON RIBBED CONDOMS | Safetex Corp. | 1990-07-24 | 49 | 0 |
| K900357 | GOLD CIRCLE COIN | Safetex Corp. | 1990-04-02 | 67 | 0 |
| K900360 | SAXON ULTRA THIN | Safetex Corp. | 1990-04-02 | 67 | 0 |
| K900359 | EMBRACE | Safetex Corp. | 1990-04-02 | 67 | 0 |
| K900358 | SAXON WET LUBE | Safetex Corp. | 1990-04-02 | 67 | 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