Suretex Limited: FDA clearances and approvals
Suretex Limited has 6 FDA 510(k) clearances (first 2022, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time: 127 days. Since 2017 its median was 127 days, against 140 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 2 | 142 |
| 2023 | 2 | 93 |
| 2024 | 1 | 267 |
| 2025 | 1 | 99 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Suretex Limited's cleared 510(k)s took a median 127 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIS | Condom | 3 | 3 |
| MOL | Condom, Synthetic | 2 | 2 |
| NUC | Lubricant, Personal | 1 | 1 |
Review panels
Most recent Suretex Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex Condom | HIS | 2025-11-18 | 99 |
| K232470 | Polyisoprene Extra Large Condom | MOL | 2024-05-09 | 267 |
| K231908 | 45 Micron Polyisoprene Condom | MOL | 2023-10-27 | 120 |
| K232279 | LifeStyles NRL Textured Condom | HIS | 2023-10-05 | 66 |
| K221243 | OFNat Lubricant (L15) | NUC | 2022-09-30 | 151 |
| K213921 | Microthin Natural Rubber Latex Condom | HIS | 2022-04-28 | 134 |
Recalls
openFDA lists no recalls under a recalling firm named Suretex Limited.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Suretex Limited have?
Suretex Limited has 6 FDA 510(k) clearances (first 2022, latest 2025), across 3 product codes in 1 review panel.
How long does FDA take to clear Suretex Limited's 510(k)s?
The median time from FDA receipt to decision across Suretex Limited's cleared 510(k)s is 127 days. Since 2017: 127 days, versus 140 days for all cleared 510(k)s in the same product codes.
What devices does Suretex Limited make?
Its most frequent FDA product codes are HIS (Condom, 3); MOL (Condom, Synthetic, 2); NUC (Lubricant, Personal, 1).
Has Suretex Limited had device recalls?
openFDA lists no recalls under a recalling firm name matching Suretex Limited. Related entities may recall under other names.
Next steps
- See all 6 Suretex Limited clearances with predicates and recalls
- Run predicate analysis for product code HIS, Suretex Limited's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.