Cleared Traditional

K910318 - BARD HYDROGEL/SILVER-COATED FOLEY CATHETER

K910318 is the FDA 510(k) clearance for BARD HYDROGEL/SILVER-COATED FOLEY CATHETER by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code MJC) cleared through the Traditional 510(k) pathway after a 1302-day FDA review.

K910318 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Aug 1994
Decision
1302d
Days
Class 2
Risk

K910318 is an FDA 510(k) clearance for the BARD(R) HYDROGEL/SILVER-COATED 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 August 18, 1994 after a review of 1302 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. 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.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K910318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1991
Decision Date August 18, 1994
Days to Decision 1302 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1172d slower than avg
Panel avg: 130d · This submission: 1302d
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.