Cleared Traditional

K023872 - VITALCARE URETHRAL CATHETER RED RUBBER

K023872 is an FDA 510(k) clearance for VITALCARE URETHRAL CATHETER RED RUBBER, manufactured by Vitalcare, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K023872 · Vitalcare, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
141d
Days
Class 2
Risk

K023872 is an FDA 510(k) clearance for the VITALCARE URETHRAL CATHETER RED RUBBER. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Vitalcare, Inc. (Miami, US). The FDA issued a Cleared decision on April 10, 2003 after a review of 141 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.

View all Vitalcare, Inc. devices

FDA 510(k) Submission Details - K023872

510(k) Number K023872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2002
Decision Date April 10, 2003
Days to Decision 141 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
10d slower than avg
Panel avg: 131d · This submission: 141d
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 84
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K023872.
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
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BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER
K041464 · Busse Hospital Disposables · Nov 2004
SLIP UROLOGY CATHETER
K040519 · Percutaneous Systems, Inc. · May 2004
AMERICAN CATHETER, MODEL W3
K030538 · Catheter, LLC · Mar 2003
MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006
K993226 · Memcath Technologies, LLC · Dec 1999
KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
K973546 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1997