Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Suretex, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
132 daysmedian FDA review time
630 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030176 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH | Suretex, Ltd. | 2003-04-17 | 90 | 0 |
| K010371 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WIT | Suretex, Ltd. | 2001-04-27 | 79 | 0 |
| K941258 | LATEX CONDOM | Suretex, Ltd. | 1995-12-06 | 630 | 1 |
| K942858 | LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9) | Suretex, Ltd. | 1995-05-18 | 428 | 0 |
| K910284 | CONDOMS (RUBBER CONTRACEPTIVES) | Suretex, Ltd. | 1991-06-04 | 132 | 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