Cleared Abbreviated

K071313 - TROJAN-ENZ BRAND

K071313 is an FDA 510(k) clearance for TROJAN-ENZ BRAND, manufactured by Church & Dwight Co., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 169-day FDA review.

K071313 · Church & Dwight Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
169d
Days
Class 2
Risk

K071313 is an FDA 510(k) clearance for the TROJAN-ENZ BRAND. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Church & Dwight Co., Inc. (Princeton, US). The FDA issued a Cleared decision on October 26, 2007 after a review of 169 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.

View all Church & Dwight Co., Inc. devices

FDA 510(k) Submission Details - K071313

510(k) Number K071313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2007
Decision Date October 26, 2007
Days to Decision 169 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
9d slower than avg
Panel avg: 160d · This submission: 169d
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 186
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K071313.
LARGE/EXTRA LAGRE CONDOM
K113061 · Karex Industries Sdn. Bhd. · Dec 2011
BILLY BOY MALE LATEX CONDOM
K111093 · Mapa GmbH · Jun 2011
TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT
K073016 · Church & Dwight Co., Inc. · Nov 2007
TROJAN THINTENSITY BRAND MALE LATEX CONDOM
K071272 · Church & Dwight Co., Inc. · Sep 2007
GREEN LOVE MALE CONTRACEPTIVE (CONDOM)
K051842 · Cupid Condom, Ltd. · Apr 2006
DICK'S FORMALWEAR MALE LATEX CONDOM
K050913 · Dick'S Formalwear, Inc. · Apr 2006