Cleared Abbreviated

K052206 - ZEUS MALE CONDOM APPLICATOR

K052206 is an FDA 510(k) clearance for ZEUS MALE CONDOM APPLICATOR, manufactured by Condax, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 396-day FDA review.

K052206 · Condax, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
396d
Days
Class 2
Risk

K052206 is an FDA 510(k) clearance for the ZEUS MALE CONDOM APPLICATOR. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Condax, LLC (Durham, US). The FDA issued a Cleared decision on September 12, 2006 after a review of 396 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K052206

510(k) Number K052206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2005
Decision Date September 12, 2006
Days to Decision 396 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
235d slower than avg
Panel avg: 161d · This submission: 396d
Pathway characteristics
Standards-based clearance path.

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 K052206.
MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)
K070830 · Karex Industries Sdn. Bhd. · May 2007
BANANA RIBBED
K063401 · Medtech Products , Ltd. · Mar 2007
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS
K062730 · Biogreen Medical Sdn. Bhd. · Oct 2006
GREEN LOVE MALE CONTRACEPTIVE (CONDOM)
K051842 · Cupid Condom, Ltd. · Apr 2006
NAKED
K060797 · Veraxis Int'L, Inc. · Apr 2006
DICK'S FORMALWEAR MALE LATEX CONDOM
K050913 · Dick'S Formalwear, Inc. · Apr 2006
K052206 · ZEUS MALE CONDOM APPLICATOR
Download PDF FDA Summary Condax, LLC