Cleared Traditional

K040658 - BARDEX I.C. LATEX FOLEY CATHETER

K040658 is an FDA 510(k) clearance for BARDEX I.C. LATEX FOLEY CATHETER, manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MJC cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K040658 · 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 2004
Decision
201d
Days
Class 2
Risk

K040658 is an FDA 510(k) clearance for the BARDEX I.C. LATEX FOLEY CATHETER. Classified as Catheter, Urological (antimicrobial) And Accessories (product code MJC), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on September 29, 2004 after a review of 201 days - an extended review 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: 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 - K040658

510(k) Number K040658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2004
Decision Date September 29, 2004
Days to Decision 201 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
70d slower than avg
Panel avg: 131d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MJC Device Classification - Class 2, Special Controls

Product Code MJC Catheter, Urological (antimicrobial) And Accessories
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 - MJC Catheter, Urological (antimicrobial) And Accessories

All 9
Devices cleared under the same product code (MJC) and FDA review panel - the closest regulatory comparables to K040658.
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HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT
K033477 · Rochester Medical Corp. · Jun 2004
SPECTRUM SILICONE FOLEY CATHETER
K000251 · Cook Urological, Inc. · Aug 2000
RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
K001143 · Rochester Medical Corp. · Jul 2000
BARDEX I.C. PEDIATRIC FOLEY CATHETER
K993464 · C.R. Bard, Inc. · Dec 1999
BARDEX LUBRI-SIL I.C. FOLEY CATHETER
K984136 · Bard Medical Div. · Feb 1999
K040658 · BARDEX I.C. LATEX FOLEY CATHETER
Download PDF FDA Summary C.R. Bard, Inc.