Cleared Traditional

Rubber Utility Catheter

K251864 · C.R. Bard, Inc. · Gastroenterology & Urology
Feb 2026
Decision
251d
Days
Class 2
Risk

About This 510(k) Submission

K251864 is an FDA 510(k) clearance for the Rubber Utility Catheter, a Catheter, Urological (Class II — Special Controls, product code KOD), submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on February 23, 2026, 251 days after receiving the submission on June 17, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K251864 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2025
Decision Date February 23, 2026
Days to Decision 251 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KOD — Catheter, Urological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

Similar Devices — KOD Catheter, Urological

All 237
Wellead Ureteral Catheter
K220036 · Well Lead Medical Co., Ltd. · Dec 2022
allFlex Ureteral Catheters, Krait Ureteral Catheters
K220730 · Allwin Medical Devices, Inc. · Oct 2022
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
K211032 · Urogen Pharma, Ltd. · Nov 2021
Rusch FloCath Quick 18 Fr. Coud? Hydrophilic Intermittent Catheter
K181979 · Teleflexmedical, Inc. · May 2019
UroGen Ureteral Catheter
K180354 · Urogen Pharma, Ltd. · Oct 2018
Angled Tip Ureteral Catheter
K181144 · Cook Incorporated · Jun 2018

More from C.R. Bard, Inc.

View all
Bard? Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
K251186 · LDF · May 2025
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH? Temporary Pacing Electrode Catheter,
K241334 · LDF · Jan 2025
Aspirex? Thrombectomy System
K230356 · QEW · Mar 2023
Highlander? 014 PTA Balloon Dilatation Catheter
K223177 · LIT · Jan 2023
WavelinQ? Generator
K222793 · GEI · Oct 2022