Cleared Traditional

Well Lead PVC Urethral Catheter (K142563) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K142563 · Well Lead Medical Co., Ltd. · Gastroenterology & Urology device
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Oct 2014
Decision
47d
Days
Class 2
Risk

K142563 is an FDA 510(k) clearance for the Well Lead PVC Urethral Catheter. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Well Lead Medical Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on October 28, 2014 after a review of 47 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Well Lead Medical Co., Ltd. devices

Submission Details

510(k) Number K142563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2014
Decision Date October 28, 2014
Days to Decision 47 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 130d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZD Catheter, Straight
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 - EZD Catheter, Straight

All 43
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K142563.
Magic3 Go Intermittent Urinary Catheter
K172247 · C.R. Bard, Inc. · Sep 2017
Magic3 Go Intermittent Urinary Catheter
K150345 · C.R. Bard, Inc. · May 2015
Bard RiteCath Intermittent Urinary Catheter
K142575 · C.R. Bard, Inc. · Oct 2014
BARD RITECATH INTERMITTENT CATHETER
K133470 · C.R. Bard, Inc. · Apr 2014
COMFORTGLIDE INTERMITENT CATHETER
K112137 · C.R. Bard, Inc. · Aug 2011
MEDLINE PVC URETHRAL CATHETER
K100302 · Medline Industries, Inc. · Jul 2010