Cleared Abbreviated

K013773 - SAFE

K013773 is an FDA 510(k) clearance for SAFE, manufactured by Ssn Medical Products Sdn. Bhd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 72-day FDA review.

K013773 · Ssn Medical Products Sdn. Bhd. · Obstetrics & Gynecology device
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Jan 2002
Decision
72d
Days
Class 2
Risk

K013773 is an FDA 510(k) clearance for the SAFE. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Ssn Medical Products Sdn. Bhd. (Petaling Jaya, Selangor, MY). The FDA issued a Cleared decision on January 24, 2002 after a review of 72 days - a notably fast clearance 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 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 - K013773

510(k) Number K013773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2001
Decision Date January 24, 2002
Days to Decision 72 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
89d faster than avg
Panel avg: 161d · This submission: 72d
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 K013773.
JOE LUBE CONDOM
K011363 · Marketing Sales Concepts, Inc. (Msci) · Mar 2002
JOE LUB HELMET CONDOM
K011378 · Marketing Sales Concepts, Inc. (Msci) · Mar 2002
INVIGRA
K020223 · Indus Medicare , Ltd. · Mar 2002
WET LIGHT PERSONAL MOISTURIZER
K013086 · Trigg Laboratories, Inc. · Dec 2001
ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
K012664 · Innolatex Sdn. Bhd · Nov 2001
ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT
K012665 · Innolatex Sdn. Bhd · Nov 2001
K013773 · SAFE
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