Cleared Traditional

K884402 - EXTRA STRENGTH SKIN LESS SKIN CONDOM

K884402 is an FDA 510(k) clearance for EXTRA STRENGTH SKIN LESS SKIN CONDOM, 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 142-day FDA review.

K884402 · Okamoto USA, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
142d
Days
Class 2
Risk

K884402 is an FDA 510(k) clearance for the EXTRA STRENGTH SKIN LESS SKIN CONDOM. 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 10, 1989 after a review of 142 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Okamoto USA, Inc. devices

FDA 510(k) Submission Details - K884402

510(k) Number K884402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1988
Decision Date March 10, 1989
Days to Decision 142 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
18d faster than avg
Panel avg: 160d · This submission: 142d
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 K884402.
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