Cleared Traditional

BARDEX I.C. LATEX FOLEY CATHETER (K040658) - FDA 510(k) Clearance

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

K040658 · C.R. Bard, Inc. · Gastroenterology & Urology device
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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.

View all C.R. Bard, Inc. devices

Submission Details

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
71d slower than avg
Panel avg: 130d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.
Wellead® Latex Foley Catheter
K233094 · Well Lead Medical (Hainan) Co., Ltd. · Jun 2024
BARDEX I.C. PEDIATRIC FOLEY CATHETER
K993464 · C.R. Bard, Inc. · Dec 1999
BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24
K983101 · C.R. Bard, Inc. · Nov 1998
BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER
K910318 · C.R. Bard, Inc. · Aug 1994