Cleared Traditional

BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER (K913341) - FDA 510(k) Clearance

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

K913341 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Jan 1992
Decision
185d
Days
Class 2
Risk

K913341 is an FDA 510(k) clearance for the BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER. Classified as Catheter, Coude (product code EZC), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on January 27, 1992 after a review of 185 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 K913341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1991
Decision Date January 27, 1992
Days to Decision 185 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
55d slower than avg
Panel avg: 130d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZC Catheter, Coude
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 - EZC Catheter, Coude

Devices cleared under the same product code (EZC) and FDA review panel - the closest regulatory comparables to K913341.
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K910846 · C.R. Bard, Inc. · Aug 1991
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K910195 · C.R. Bard, Inc. · Aug 1991
HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS
K910197 · C.R. Bard, Inc. · Aug 1991