510(k) Report

FDA applicant

Safetex Corp.

Colonial Heights, VA7 decisions1990–19930 recalls

FDA records 7 decisions for Safetex Corp. (Colonial Heights, VA) from 1990 to 1993: 7 510(k) clearances. All are in product code HIS (Condom). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Safetex Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Safetex Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Safetex Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Safetex Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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