Cleared Traditional

K001143 - RELEASE NF ANTIBACTERIAL FOLEY CATHETER

K001143 is the FDA 510(k) clearance for RELEASE NF ANTIBACTERIAL FOLEY CATHETER by Rochester Medical Corp.. It is a Class 2 Gastroenterology & Urology device (product code MJC) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K001143 · Rochester Medical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
88d
Days
Class 2
Risk

K001143 is an FDA 510(k) clearance for the RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER. Classified as Catheter, Urological (antimicrobial) And Accessories (product code MJC), Class II - Special Controls.

Submitted by Rochester Medical Corp. (Stewartville, US). The FDA issued a Cleared decision on July 7, 2000 after a review of 88 days - a notably fast clearance 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: 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 Rochester Medical Corp. devices

Submission Details

510(k) Number K001143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2000
Decision Date July 07, 2000
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 130d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MJC Catheter, Urological (antimicrobial) And Accessories
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 - MJC Catheter, Urological (antimicrobial) And Accessories

Devices cleared under the same product code (MJC) and FDA review panel - the closest regulatory comparables to K001143.
Wellead® Latex Foley Catheter
K233094 · Well Lead Medical (Hainan) Co., Ltd. · Jun 2024
BARDEX I.C. LATEX FOLEY CATHETER
K040658 · C.R. Bard, Inc. · Sep 2004
SPECTRUM SILICONE FOLEY CATHETER
K000251 · Cook Urological, Inc. · Aug 2000
BARDEX I.C. PEDIATRIC FOLEY CATHETER
K993464 · C.R. Bard, Inc. · Dec 1999
BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24
K983101 · C.R. Bard, Inc. · Nov 1998
BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER
K910318 · C.R. Bard, Inc. · Aug 1994