Cleared Traditional

K943933 - SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM

K943933 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 314-day FDA review.

K943933 · Aladan Corp. · Obstetrics & Gynecology device
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Jun 1995
Decision
314d
Days
Class 2
Risk

K943933 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. (Dothan, US). The FDA issued a Cleared decision on June 22, 1995 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K943933

510(k) Number K943933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1994
Decision Date June 22, 1995
Days to Decision 314 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
153d slower than avg
Panel avg: 161d · This submission: 314d
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 294
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K943933.
MAXX
K946376 · Mayer Laboratories · Sep 1995
PREVENTOR AND PROTECTOR LATEX CONDOMS
K945246 · American Pharmaceutical Co., Inc. · Sep 1995
OKAMOTO CONDOM
K952393 · Okamoto USA, Inc. · Aug 1995
AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI
K932985 · Sime Health, Ltd. · Jun 1995
LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)
K942858 · Suretex, Ltd. · May 1995
SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM
K943883 · Aladan Corp. · Apr 1995
K943933 · SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM
Download PDF Aladan Corp.