Cleared Abbreviated

K090259 - OKAMOTO ULTRA THIN

K090259 is an FDA 510(k) clearance for OKAMOTO ULTRA THIN, manufactured by Okamoto USA, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 57-day FDA review.

K090259 · Okamoto USA, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
57d
Days
Class 2
Risk

K090259 is an FDA 510(k) clearance for the OKAMOTO ULTRA THIN. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Okamoto USA, Inc. (Washington, US). The FDA issued a Cleared decision on March 31, 2009 after a review of 57 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 Okamoto USA, Inc. devices

FDA 510(k) Submission Details - K090259

510(k) Number K090259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2009
Decision Date March 31, 2009
Days to Decision 57 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
104d faster than avg
Panel avg: 161d · This submission: 57d
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 240
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K090259.
THAI NIPPON MALE LATEX CONDOM
K081265 · Thai Nippon Rubber Industry Co., Ltd. · Oct 2009
M. DIOR BRAND
K083817 · Suzhou Colour-Way Enterprise Development Co., Ltd. · Sep 2009
ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM
K082529 · Alatech Healthcare, LLC · May 2009
KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED
K081886 · Karex Industries Sdn. Bhd. · Feb 2009
TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM
K081413 · Dailian Latex Company, Ltd. · Oct 2008
LOVE GUARD MALE LATEX CONDOM
K080833 · Tianjin Human-Care Latex Corporation · Aug 2008