Cleared Traditional

K133470 - BARD RITECATH INTERMITTENT CATHETER

K133470 is an FDA 510(k) clearance for BARD RITECATH INTERMITTENT CATHETER, manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K133470 · 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
Apr 2014
Decision
143d
Days
Class 2
Risk

K133470 is an FDA 510(k) clearance for the BARD RITECATH INTERMITTENT CATHETER. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on April 4, 2014 after a review of 143 days - within the typical 510(k) review window.

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 - K133470

510(k) Number K133470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2013
Decision Date April 04, 2014
Days to Decision 143 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
12d slower than avg
Panel avg: 131d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZD Device Classification - Class 2, Special Controls

Product Code EZD Catheter, Straight
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 - EZD Catheter, Straight

All 85
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K133470.
Bard RiteCath Intermittent Urinary Catheter
K142575 · C.R. Bard, Inc. · Oct 2014
Well Lead PVC Urethral Catheter
K142563 · Well Lead Medical Co., Ltd. · Oct 2014
COMPACTCATH INTERMITTENT URINARY CATHETER
K140945 · Compactcath, Inc. · Aug 2014
WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER
K133615 · Well Lead Medical Co., Ltd. · Feb 2014
CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED
K132500 · Cure Medical, LLC · Dec 2013
CLASSIC INTERMITTENT CATHETER
K132619 · Flexicare Medical, Ltd. · Oct 2013
K133470 · BARD RITECATH INTERMITTENT CATHETER
Download PDF FDA Summary C.R. Bard, Inc.