Cleared Traditional

K834591 - STOPEX-CONDOMS-

K834591 is an FDA 510(k) clearance for STOPEX-CONDOMS-, manufactured by Tropex Worldwide, Inc.. The device is a Class 2 Obstetrics & Gynecology device with 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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Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K834591

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 161d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIS Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HIS Condom

All 396
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K834591.
WRINKLE CHAPEAU BLACKY
K842502 · Circle Rubber Corp. · Sep 1984
ULTRA SHAPE CONDOMS
K833365 · Barnetts, Inc. · Aug 1984
PROTEX CONTRACEPT PLUS W/SPERM-LUB
K842185 · National Sanitary Laboratories, Inc. · Jul 1984
TROJAN PLUS II
K833765 · Youngs Rubber Corp. · Dec 1983
PROTEX CONTRACEPT PLUS W/SPERM-LUB
K831816 · National Sanitary Laboratories, Inc. · Sep 1983
PRIME
K830691 · Ansell, Inc. · Mar 1983
K834591 · STOPEX-CONDOMS-
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