Cleared Special

K113061 - LARGE/EXTRA LAGRE CONDOM (FDA 510(k) Clearance)

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

K113061 · Karex Industries Sdn. Bhd. · Obstetrics & Gynecology device
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Dec 2011
Decision
54d
Days
Class 2
Risk

K113061 is an FDA 510(k) clearance for the LARGE/EXTRA LAGRE CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Karex Industries Sdn. Bhd. (Johor Darul Takzim, MY). The FDA issued a Cleared decision on December 7, 2011 after a review of 54 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Karex Industries Sdn. Bhd. devices

Submission Details

510(k) Number K113061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2011
Decision Date December 07, 2011
Days to Decision 54 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 160d · This submission: 54d
Pathway characteristics
Modification to existing cleared device.

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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