Cleared Traditional

K091516 - WELL LEAD SILICONE CATHETER WITH TEMPER...

K091516 is an FDA 510(k) clearance for WELL LEAD SILICONE CATHETER WITH TEMPER..., manufactured by Well Lead Medical Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K091516 · Well Lead Medical Co., Ltd. · Gastroenterology & Urology device
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Oct 2009
Decision
147d
Days
Class 2
Risk

K091516 is an FDA 510(k) clearance for the WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Well Lead Medical Co., Ltd. (Appollo Beach, US). The FDA issued a Cleared decision on October 16, 2009 after a review of 147 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.

View all Well Lead Medical Co., Ltd. devices

FDA 510(k) Submission Details - K091516

510(k) Number K091516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2009
Decision Date October 16, 2009
Days to Decision 147 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
17d slower than avg
Panel avg: 130d · This submission: 147d
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 66
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K091516.
Bard LubriGuard Foley Catheter
K150699 · C.R. Bard, Inc. · Jul 2015
Medline Silicone Foley Catheter
K142635 · Medline Industries, Inc. · Jan 2015
AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER
K101824 · Amsino International, Inc. · Sep 2010
3 WAY SILICONE FOLEY BALLOON CATHETER
K091767 · Cook Urological, Inc. · Oct 2009
AMSURE HYDROPHILIC LATEX FOLEY CATHETER
K091699 · Amsino International, Inc. · Aug 2009
BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS
K070558 · C.R. Bard, Inc. · Dec 2007