FDA applicant
Suretex Limited
FDA records 11 decisions for Suretex Limited (Tambon Khao Kwai, Amphur Phunphin, TH) from 1991 to 2025: 11 510(k) clearances. Most are in product codes HIS (Condom) and MOL (Condom, Synthetic). Since 2016 its 510(k)s took a median of 143 days from receipt to decision, against 112 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Suretex, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Suretex Limited’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2012
Class I Class II/III not classified
Planning a device like Suretex Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Suretex”
FDA records each applicant name separately; these may or may not be the same firm.