Cleared Traditional

K943883 - SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM

K943883 is an FDA 510(k) clearance for SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM, manufactured by Aladan Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K943883 · Aladan Corp. · Obstetrics & Gynecology device
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Apr 1995
Decision
248d
Days
Class 2
Risk

K943883 is an FDA 510(k) clearance for the SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Aladan Corp. (Colonial Heights, US). The FDA issued a Cleared decision on April 14, 1995 after a review of 248 days - an extended review 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: 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 Aladan Corp. devices

FDA 510(k) Submission Details - K943883

510(k) Number K943883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1994
Decision Date April 14, 1995
Days to Decision 248 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 160d · This submission: 248d
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 82
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K943883.
KIMONO (CONDOMS)
K943064 · Mayer Laboratories · Sep 1995
MAXX
K946376 · Mayer Laboratories · Sep 1995
SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM
K943933 · Aladan Corp. · Jun 1995
CONDOM
K940045 · Ansell, Inc. · Jan 1995
NON-LUBRICATED CONDOM
K940046 · Ansell, Inc. · Jan 1995
TROJAN (TM-TBD) CONDOM
K912901 · Carter Products · Feb 1992