Cleared Traditional

K884401 - SKIN LESS SKIN CONDOM W/SPERMICIDAL LUB...

K884401 is an FDA 510(k) clearance for SKIN LESS SKIN CONDOM W/SPERMICIDAL LUB..., 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 85-day FDA review.

K884401 · Okamoto USA, Inc. · Obstetrics & Gynecology device
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Jan 1989
Decision
85d
Days
Class 2
Risk

K884401 is an FDA 510(k) clearance for the SKIN LESS SKIN CONDOM W/SPERMICIDAL 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 January 12, 1989 after a review of 85 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 - K884401

510(k) Number K884401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1988
Decision Date January 12, 1989
Days to Decision 85 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
75d faster than avg
Panel avg: 160d · This submission: 85d
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 60
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K884401.
MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT
K895640 · Armkel, LLC · Jan 1990
HSV-CHECK(TM) TEST KIT
K890819 · Diagnostic Technology, Inc. · Jun 1989
TROJAN FOR WOMEN
K890863 · Armkel, LLC · Apr 1989
KISS OF MINT(TM) NON-LUBRICATED CONDOM
K882389 · Ansell, Inc. · Oct 1988
LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9
K871304 · Ansell, Inc. · Jun 1987
EXTRA STRONG CONDOM
K864400 · Ansell, Inc. · Feb 1987