Cleared Traditional

WELL LEAD SILICONE AND LATEX FOLEY CATHETERS (K082815) - FDA 510(k) Clearance

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

K082815 · Well Lead Medical Instruments · Gastroenterology & Urology device
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Oct 2008
Decision
13d
Days
Class 2
Risk

K082815 is an FDA 510(k) clearance for the WELL LEAD SILICONE AND LATEX FOLEY CATHETERS. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Well Lead Medical Instruments (Guangzhou City, CN). The FDA issued a Cleared decision on October 8, 2008 after a review of 13 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 Instruments devices

Submission Details

510(k) Number K082815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2008
Decision Date October 08, 2008
Days to Decision 13 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 130d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 46
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K082815.
Bard LubriGuard Foley Catheter
K150699 · C.R. Bard, Inc. · Jul 2015
Medline Silicone Foley Catheter
K142635 · Medline Industries, Inc. · Jan 2015
3 WAY SILICONE FOLEY BALLOON CATHETER
K091767 · Cook Urological, Inc. · Oct 2009
BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS
K070558 · C.R. Bard, Inc. · Dec 2007
BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS
K070582 · C.R. Bard, Inc. · Dec 2007
MEDLINE LATEX FOLEY CATHETER
K071423 · Medline Industries, Inc. · Jul 2007