Cleared Traditional

K902804 - EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT

K902804 is an FDA 510(k) clearance for EXTEND STABILITY DATE FOR CONDOM W/SPER..., manufactured by Okamoto USA, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K902804 · Okamoto USA, Inc. · Obstetrics & Gynecology device
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Aug 1990
Decision
47d
Days
Class 2
Risk

K902804 is an FDA 510(k) clearance for the EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Okamoto USA, Inc. (Washington, US). The FDA issued a Cleared decision on August 13, 1990 after a review of 47 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Okamoto USA, Inc. devices

FDA 510(k) Submission Details - K902804

510(k) Number K902804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1990
Decision Date August 13, 1990
Days to Decision 47 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 161d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 256
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K902804.
TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.
K902305 · Armkel, LLC · Mar 1991
TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR
K904000 · Armkel, LLC · Feb 1991
CONDOM (RUBBER) CONTRACEPTIVE
K905279 · Aladan Corp. · Feb 1991
TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED
K901202 · Carter Products · Jun 1990
CONDOM (RUBBER) CONTRACEPTIVE
K901416 · Aladan Corp. · Jun 1990
TROJANS LATEX CONDOMS (MODIFIED LABELING)
K901190 · Carter Products · Apr 1990