Cleared Abbreviated

K150828 - O-RING Condom

K150828 is an FDA 510(k) clearance for O-RING Condom, manufactured by O-Ring Products, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 263-day FDA review.

K150828 · O-Ring Products, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
263d
Days
Class 2
Risk

K150828 is an FDA 510(k) clearance for the O-RING Condom. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by O-Ring Products, LLC (Raleigh, US). The FDA issued a Cleared decision on December 18, 2015 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. 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 - K150828

510(k) Number K150828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2015
Decision Date December 18, 2015
Days to Decision 263 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 161d · This submission: 263d
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 356
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K150828.
Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant
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Lelo Hex Natural Rubber Latex Condom
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Banana Gold
K150857 · Hankook Latex Gongup Co., Ltd. · Aug 2015
TheyFit Male Condom
K150072 · Theyfit · Apr 2015
SKORE AND MULTIPLE BRANDS
K132490 · Ttk Protective Devices Limited (Formerly Ttk-Lig L · Oct 2014
K150828 · O-RING Condom
Download PDF FDA Summary O-Ring Products, LLC