Cleared Abbreviated

K083817 - M. DIOR BRAND

K083817 is an FDA 510(k) clearance for M. DIOR BRAND, manufactured by Suzhou Colour-Way Enterprise Development Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 268-day FDA review.

K083817 · Suzhou Colour-Way Enterprise Development Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
268d
Days
Class 2
Risk

K083817 is an FDA 510(k) clearance for the M. DIOR BRAND. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Suzhou Colour-Way Enterprise Development Co., Ltd. (Haidian District, Beijing, CN). The FDA issued a Cleared decision on September 16, 2009 after a review of 268 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 - K083817

510(k) Number K083817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2008
Decision Date September 16, 2009
Days to Decision 268 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 161d · This submission: 268d
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 275
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K083817.
BILLY BOY MALE LATEX CONDOM
K103119 · Sheila Pickering PHD · Feb 2011
MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU
K092586 · Innolatex (Thailand) Limited · May 2010
THAI NIPPON MALE LATEX CONDOM
K081265 · Thai Nippon Rubber Industry Co., Ltd. · Oct 2009
ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM
K082529 · Alatech Healthcare, LLC · May 2009
OKAMOTO ULTRA THIN
K090259 · Okamoto USA, Inc. · Mar 2009
KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED
K081886 · Karex Industries Sdn. Bhd. · Feb 2009