Cleared Abbreviated

SAFE (K013773) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

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.

View all Ssn Medical Products Sdn. Bhd. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 160d · This submission: 72d
Pathway characteristics
Standards-based clearance path.

Device Classification

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.

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