Cleared Traditional

K142635 - Medline Silicone Foley Catheter

K142635 is an FDA 510(k) clearance for Medline Silicone Foley Catheter, manufactured by Medline Industries, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K142635 · Medline Industries, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
114d
Days
Class 2
Risk

K142635 is an FDA 510(k) clearance for the Medline Silicone Foley Catheter. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on January 9, 2015 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K142635

510(k) Number K142635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2014
Decision Date January 09, 2015
Days to Decision 114 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 131d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZL Device Classification - Class 2, Special Controls

Product Code EZL Catheter, Retention Type, Balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - EZL Catheter, Retention Type, Balloon

All 123
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K142635.
Accuryn Monitoring System
K153655 · Potrero Medical, Inc. · Apr 2016
SilverCoat Silicone Foley Catheter
K150550 · Covalontechnologies, Inc. · Nov 2015
Bard LubriGuard Foley Catheter
K150699 · C.R. Bard, Inc. · Jul 2015
WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
K140667 · Well Lead Medical Co., Ltd. · Dec 2014
LIGHTHOUSE URINARY CATHETER
K140099 · Seedings Life Science Ventures, LLC · Mar 2014
LIGHTHOUSE(TM) URINARY CATHETER
K131655 · Seedings Life Science Ventures, LLC · Nov 2013
K142635 · Medline Silicone Foley Catheter
Download PDF FDA Summary Medline Industries, I…