Cleared Abbreviated

K072747 - UNIDUS MAGNUM MALE LATEX CONDOM

K072747 is an FDA 510(k) clearance for UNIDUS MAGNUM MALE LATEX CONDOM, manufactured by Unidus Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 49-day FDA review.

K072747 · Unidus Corp. · Obstetrics & Gynecology device
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Nov 2007
Decision
49d
Days
Class 2
Risk

K072747 is an FDA 510(k) clearance for the UNIDUS MAGNUM MALE LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Unidus Corp. (Tuscaloosa, US). The FDA issued a Cleared decision on November 15, 2007 after a review of 49 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 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 Unidus Corp. devices

FDA 510(k) Submission Details - K072747

510(k) Number K072747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2007
Decision Date November 15, 2007
Days to Decision 49 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
111d faster than avg
Panel avg: 160d · This submission: 49d
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 196
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K072747.
LARGE/EXTRA LAGRE CONDOM
K113061 · Karex Industries Sdn. Bhd. · Dec 2011
BILLY BOY MALE LATEX CONDOM
K111093 · Mapa GmbH · Jun 2011
RICHTER MALE LATEX CONDOM
K070511 · Richter Rubber Technology Sbn Bhd · Jan 2008
TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT
K073016 · Church & Dwight Co., Inc. · Nov 2007
TROJAN-ENZ BRAND
K071313 · Church & Dwight Co., Inc. · Oct 2007
MULTIPLE BRAND MALE LATEX CONDOM
K070937 · Nulatex Sdn. Bhd. · Sep 2007