Cleared Abbreviated

K182438 - Synthetic Polyisoprene Lubricated Male Condom - 5 senses (FDA 510(k) Clearance)

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

K182438 · Sxwell USA, LLC · Obstetrics & Gynecology device
Dec 2018
Decision
90d
Days
Class 2
Risk

K182438 is an FDA 510(k) clearance for the Synthetic Polyisoprene Lubricated Male Condom - 5 senses. Classified as Condom, Synthetic (product code MOL), Class II - Special Controls.

Submitted by Sxwell USA, LLC (Iselin, US). The FDA issued a Cleared decision on December 6, 2018 after a review of 90 days - within the typical 510(k) review window.

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.

Submission Details

510(k) Number K182438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2018
Decision Date December 06, 2018
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 158d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MOL Condom, Synthetic
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.