Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Suretex Limited — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
134 daysmedian FDA review time
267 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex Condom | Suretex Limited | 2025-11-18 | 99 | 0 |
| K232470 | Polyisoprene Extra Large Condom | Suretex Limited | 2024-05-09 | 267 | 0 |
| K231908 | 45 Micron Polyisoprene Condom | Suretex Limited | 2023-10-27 | 120 | 0 |
| K232279 | LifeStyles NRL Textured Condom | Suretex Limited | 2023-10-05 | 66 | 0 |
| K221243 | OFNat Lubricant (L15) | Suretex Limited | 2022-09-30 | 151 | 0 |
| K213921 | Microthin Natural Rubber Latex Condom | Suretex Limited | 2022-04-28 | 134 | 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