Cleared Abbreviated

K031007 - KWIKEZE MALE CONDOM APPLICATOR

K031007 is an FDA 510(k) clearance for KWIKEZE 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 228-day FDA review.

K031007 · Condax, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
228d
Days
Class 2
Risk

K031007 is an FDA 510(k) clearance for the KWIKEZE 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 November 14, 2003 after a review of 228 days - an extended review 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 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 - K031007

510(k) Number K031007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2003
Decision Date November 14, 2003
Days to Decision 228 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
67d slower than avg
Panel avg: 161d · This submission: 228d
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 K031007.
LONG LOVE CONDOM
K033541 · Unidus Corp. · Dec 2003
LIFESTYLES LIQUID PERSONAL LUBRICANT
K033076 · Ansell Healthcare, Inc. · Dec 2003
THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM
K032909 · Thai Nippon Rubber Industry Co., Ltd. · Dec 2003
MERCATOR HEALTHCARE MALE LATEX CONDOM
K031369 · Mercator Healthcare , Ltd. · Oct 2003
MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR
K023333 · Pleasure Latex Products Sdn. Bhd. · Jun 2003
LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT
K030176 · Suretex, Ltd. · Apr 2003
K031007 · KWIKEZE MALE CONDOM APPLICATOR
Download PDF FDA Summary Condax, LLC