Cleared Traditional

K984136 - BARDEX LUBRI-SIL I.C. FOLEY CATHETER

K984136 is an FDA 510(k) clearance for BARDEX LUBRI-SIL I.C. FOLEY CATHETER, manufactured by Bard Medical Div.. The device is a Class 2 Gastroenterology & Urology device with product code MJC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K984136 · Bard Medical Div. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
90d
Days
Class 2
Risk

K984136 is an FDA 510(k) clearance for the BARDEX LUBRI-SIL I.C. FOLEY CATHETER. Classified as Catheter, Urological (antimicrobial) And Accessories (product code MJC), Class II - Special Controls.

Submitted by Bard Medical Div. (Covington, US). The FDA issued a Cleared decision on February 16, 1999 after a review of 90 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 Bard Medical Div. devices

FDA 510(k) Submission Details - K984136

510(k) Number K984136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1998
Decision Date February 16, 1999
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MJC Device Classification - Class 2, Special Controls

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 K984136.
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