Cleared Traditional

K933153 - PENTHOUSE CONDOMS

K933153 is an FDA 510(k) clearance for PENTHOUSE CONDOMS, manufactured by Kuron Health Products Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 394-day FDA review.

K933153 · Kuron Health Products Corp. · Obstetrics & Gynecology device
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Jul 1994
Decision
394d
Days
Class 2
Risk

K933153 is an FDA 510(k) clearance for the PENTHOUSE CONDOMS. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Kuron Health Products Corp. (Oakland, US). The FDA issued a Cleared decision on July 28, 1994 after a review of 394 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 - K933153

510(k) Number K933153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1993
Decision Date July 28, 1994
Days to Decision 394 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
233d slower than avg
Panel avg: 161d · This submission: 394d
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 368
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K933153.
LUBRICATING JELLY
K941831 · Barre-National, Inc. · Jan 1995
TACTYLON(TM) CONDOM
K911431 · Tactyl Technologies, Inc. · Dec 1994
LATEX PROPHYLACTIC RUBBER CONTRACEPTIVE
K931077 · J.K. Chemicals, Ltd. · Sep 1994
SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)
K932982 · Sime Health, Ltd. · Jul 1994
COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)
K932983 · Sime Health, Ltd. · Jul 1994
UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI
K932984 · Sime Health, Ltd. · Jul 1994
K933153 · PENTHOUSE CONDOMS
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