Cleared Traditional

K050875 - U-BALLOON DILATION CATHETER

K050875 is the FDA 510(k) clearance for U-BALLOON DILATION CATHETER by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code EZN) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K050875 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
50d
Days
Class 2
Risk

K050875 is an FDA 510(k) clearance for the U-BALLOON DILATION CATHETER. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on May 26, 2005 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5470 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K050875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2005
Decision Date May 26, 2005
Days to Decision 50 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
80d faster than avg
Panel avg: 130d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZN Dilator, Catheter, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5470
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 - EZN Dilator, Catheter, Ureteral

All 43
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K050875.
Balloon Catheter and Balloon Ureteral Dilator Set
K172588 · Cook Incorporated · Apr 2018
Ureteral Dilators and Percutaneous Nephrostomy Dilators
K170531 · Coloplast Corp. · Aug 2017
UROMAX ULTRA BALLOON DILATATION CATHETER
K130804 · Boston Scientific Corporation · May 2013
COOK URETERAL BALLOON DILATION CATHETER SET
K040127 · Cook Urological, Inc. · Apr 2004
BARD UROFORCE BALLOON DILATION CATHETER
K993840 · C.R. Bard, Inc. · Jan 2000
BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C
K990072 · Cook Urological, Inc. · Mar 1999