Cleared Abbreviated

K002612 - BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON

K002612 is an FDA 510(k) clearance for BARDEX I.C.PLUS FOLEY CATHETER WITH SIL..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Abbreviated 510(k) pathway after a 743-day FDA review.

K002612 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
743d
Days
Class 2
Risk

K002612 is an FDA 510(k) clearance for the BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3.... Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on September 3, 2002 after a review of 743 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

FDA 510(k) Submission Details - K002612

510(k) Number K002612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2000
Decision Date September 03, 2002
Days to Decision 743 days
Submission Type Abbreviated
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
612d slower than avg
Panel avg: 131d · This submission: 743d
Pathway characteristics
Standards-based clearance path.

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 130
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K002612.
OPTION-VF URINARY CATHETER, FV14218
K023090 · Opticon Medical, Inc. · Mar 2003
ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
K021142 · Fortune Medical Instrument Corp. · Oct 2002
3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS
K022287 · 3t Medical Systems, LLC · Sep 2002
ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY
K013276 · Sewoon Medical Co., Ltd. · Feb 2002
PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,
K013174 · Porges S.A. · Jan 2002
PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL
K013172 · Porges S.A. · Dec 2001
K002612 · BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON
Download PDF FDA Summary C.R. Bard, Inc.