Cleared Abbreviated

K132490 - SKORE AND MULTIPLE BRANDS

K132490 is an FDA 510(k) clearance for SKORE AND MULTIPLE BRANDS, manufactured by Ttk Protective Devices Limited (Formerly Ttk-Lig L. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 438-day FDA review.

K132490 · Ttk Protective Devices Limited (Formerly Ttk-Lig L · Obstetrics & Gynecology device
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Oct 2014
Decision
438d
Days
Class 2
Risk

K132490 is an FDA 510(k) clearance for the SKORE AND MULTIPLE BRANDS. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Ttk Protective Devices Limited (Formerly Ttk-Lig L (Aurora, US). The FDA issued a Cleared decision on October 20, 2014 after a review of 438 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: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

FDA 510(k) Submission Details - K132490

510(k) Number K132490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2013
Decision Date October 20, 2014
Days to Decision 438 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
277d slower than avg
Panel avg: 161d · This submission: 438d
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 357
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K132490.
O-RING Condom
K150828 · O-Ring Products, LLC · Dec 2015
Banana Gold
K150857 · Hankook Latex Gongup Co., Ltd. · Aug 2015
TheyFit Male Condom
K150072 · Theyfit · Apr 2015
NATURAL RUBBER LATEX MALE CONDOMS
K141059 · Karex Industries Sdn. Bhd. · Aug 2014
OKAMOTO STUDDED CONDOM
K141256 · Okamoto USA, Inc. · Jul 2014
MEGA BIG BOY CONDOM
K140379 · Okamoto USA, Inc. · Jul 2014
K132490 · SKORE AND MULTIPLE BRANDS
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