Cleared Traditional

K834591 - STOPEX-CONDOMS-

K834591 is the FDA 510(k) clearance for STOPEX-CONDOMS- by Tropex Worldwide, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIS) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K834591 · Tropex Worldwide, Inc. · Obstetrics & Gynecology device
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Feb 1984
Decision
37d
Days
Class 2
Risk

K834591 is an FDA 510(k) clearance for the STOPEX-CONDOMS-. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Tropex Worldwide, Inc. (Walker, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tropex Worldwide, Inc. devices

Submission Details

510(k) Number K834591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1983
Decision Date February 04, 1984
Days to Decision 37 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 160d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIS Condom
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.