Cleared Abbreviated

K023059 - UNIDUS MALE LATEX CONDOM

K023059 is an FDA 510(k) clearance for UNIDUS 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 90-day FDA review.

K023059 · Unidus Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
90d
Days
Class 2
Risk

K023059 is an FDA 510(k) clearance for the UNIDUS MALE LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Unidus Corp. (Durham, US). The FDA issued a Cleared decision on December 12, 2002 after a review of 90 days - within the typical 510(k) review window.

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 - K023059

510(k) Number K023059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2002
Decision Date December 12, 2002
Days to Decision 90 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
71d faster than avg
Panel avg: 161d · This submission: 90d
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 401
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K023059.
UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK)
K023129 · Unidus Corp. · Dec 2002
UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING)
K023175 · Unidus Corp. · Dec 2002
UNDUS MALE LATEX CONDOM (WITH FLAVORING)
K023176 · Unidus Corp. · Dec 2002
SENSUA!
K021125 · Aac Consulting Group, Inc. · Oct 2002
CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG,
K021186 · Condomi Erfert Prodoktionsgesellschaft Mbh · Oct 2002
MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM
K021875 · Pleasure Latex Products Sdn. Bhd. · Sep 2002
K023059 · UNIDUS MALE LATEX CONDOM
Download PDF FDA Summary Unidus Corp.