Cleared Traditional

K896623 - SAFECON CONDOMS - PINK COLOR

K896623 is an FDA 510(k) clearance for SAFECON CONDOMS - PINK COLOR, manufactured by Quality Synthetics Intl, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K896623 · Quality Synthetics Intl, Inc. · Obstetrics & Gynecology device
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Feb 1990
Decision
87d
Days
Class 2
Risk

K896623 is an FDA 510(k) clearance for the SAFECON CONDOMS - PINK COLOR. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Quality Synthetics Intl, Inc. (Garden Grove, US). The FDA issued a Cleared decision on February 16, 1990 after a review of 87 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 Quality Synthetics Intl, Inc. devices

FDA 510(k) Submission Details - K896623

510(k) Number K896623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1989
Decision Date February 16, 1990
Days to Decision 87 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
73d faster than avg
Panel avg: 160d · This submission: 87d
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 202
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K896623.
TROJAN RIBBED LATEX CONDOMS W/SPERM. MODIFIED
K901201 · Carter Products · Apr 1990
NUDA (CURRENTLY CALLED ULTRA SENSITIVE)
K901111 · Ansell, Inc. · Mar 1990
G.S.A. COLORED CONDOMS
K901112 · Ansell, Inc. · Mar 1990
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