Cleared Traditional

K946207 - CONQUEROR, RUMBA AND TEMPTATION

K946207 is an FDA 510(k) clearance for CONQUEROR, manufactured by Frontline Latex Products Pvt. , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 399-day FDA review.

K946207 · Frontline Latex Products Pvt. , Ltd. · Obstetrics & Gynecology device
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Jan 1996
Decision
399d
Days
Class 2
Risk

K946207 is an FDA 510(k) clearance for the CONQUEROR, RUMBA AND TEMPTATION. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Frontline Latex Products Pvt. , Ltd. (New York, US). The FDA issued a Cleared decision on January 24, 1996 after a review of 399 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.

View all Frontline Latex Products Pvt. , Ltd. devices

FDA 510(k) Submission Details - K946207

510(k) Number K946207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1994
Decision Date January 24, 1996
Days to Decision 399 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
239d slower than avg
Panel avg: 160d · This submission: 399d
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 146
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K946207.
RIA LATEX CONDOM, NONOXYNOL-9
K945145 · Mbf Personal Care Sdn. Bhd. · Feb 1996
RIA LATEX CONDOM
K943880 · Mbf Personal Care Sdn. Bhd. · Feb 1996
LUBRICATED CONDOM
K953583 · Tactyl Technologies, Inc. · Jan 1996
SEMINAL FLUID COLLECTION KIT II
K954791 · Apex Medical Technologies, Inc. · Jan 1996
SPERMICIDALLY LUBRICATED CONDOM
K940047 · Ansell, Inc. · Dec 1995
KIMONO MICROTHIN
K946374 · Mayer Laboratories · Nov 1995