Cleared Special

K113056 - ORANGE COLORED CONDOMS ORANGE SCENT (FDA 510(k) Clearance)

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

K113056 · Karex Industries Sdn. Bhd. · Obstetrics & Gynecology device
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Jul 2012
Decision
263d
Days
Class 2
Risk

K113056 is an FDA 510(k) clearance for the ORANGE COLORED CONDOMS ORANGE SCENT. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Karex Industries Sdn. Bhd. (Pontian Kecil, Jalan Johor, MY). The FDA issued a Cleared decision on July 3, 2012 after a review of 263 days - an extended review 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. Standard predicate reliance. 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 K113056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2011
Decision Date July 03, 2012
Days to Decision 263 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
103d slower than avg
Panel avg: 160d · This submission: 263d
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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