Cleared Traditional

K890863 - TROJAN FOR WOMEN

K890863 is an FDA 510(k) clearance for TROJAN FOR WOMEN, manufactured by Armkel, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K890863 · Armkel, LLC · Obstetrics & Gynecology device
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Apr 1989
Decision
42d
Days
Class 2
Risk

K890863 is an FDA 510(k) clearance for the TROJAN FOR WOMEN. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on April 4, 1989 after a review of 42 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.

FDA 510(k) Submission Details - K890863

510(k) Number K890863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1989
Decision Date April 04, 1989
Days to Decision 42 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 161d · This submission: 42d
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 401
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K890863.
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K884454 · Quality Synthetics Intl, Inc. · Apr 1989
SUPER MAXX OTHERS (MULTIPLE) CONDOMS
K884468 · Mayer Laboratories · Mar 1989
ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS
K884469 · Mayer Laboratories · Mar 1989
KIMONO PLUS OTHERS (MULTIPLE) CONDOMS
K884470 · Mayer Laboratories · Mar 1989
K890863 · TROJAN FOR WOMEN
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