Cleared Abbreviated

K011363 - JOE LUBE CONDOM

K011363 is an FDA 510(k) clearance for JOE LUBE CONDOM, manufactured by Marketing Sales Concepts, Inc. (Msci). The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 326-day FDA review.

K011363 · Marketing Sales Concepts, Inc. (Msci) · Obstetrics & Gynecology device
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Mar 2002
Decision
326d
Days
Class 2
Risk

K011363 is an FDA 510(k) clearance for the JOE LUBE CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Marketing Sales Concepts, Inc. (Msci) (Atlanta, US). The FDA issued a Cleared decision on March 25, 2002 after a review of 326 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K011363

510(k) Number K011363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2001
Decision Date March 25, 2002
Days to Decision 326 days
Submission Type Abbreviated
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
165d slower than avg
Panel avg: 161d · This submission: 326d
Pathway characteristics
Standards-based clearance path.

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 396
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K011363.
NATURAL AND COLORED LATEX CONDOM WITH FLAVORS
K020633 · Ls Rubber Sdn Bhd · May 2002
MALE LATEX CONDOM WITH RIBBED SURFACE
K020272 · Pleasure Latex Products Sdn. Bhd. · Apr 2002
DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
K020659 · Ssl Americas, Inc. · Mar 2002
JOE LUB HELMET CONDOM
K011378 · Marketing Sales Concepts, Inc. (Msci) · Mar 2002
INVIGRA
K020223 · Indus Medicare , Ltd. · Mar 2002
SAFE
K013773 · Ssn Medical Products Sdn. Bhd. · Jan 2002
K011363 · JOE LUBE CONDOM
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