Cleared Abbreviated

BARDEX I.C. PEDIATRIC FOLEY CATHETER (K993464) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K993464 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
58d
Days
Class 2
Risk

K993464 is an FDA 510(k) clearance for the BARDEX I.C. PEDIATRIC FOLEY CATHETER. Classified as Catheter, Urological (antimicrobial) And Accessories (product code MJC), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on December 10, 1999 after a review of 58 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K993464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1999
Decision Date December 10, 1999
Days to Decision 58 days
Submission Type Abbreviated
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
72d faster than avg
Panel avg: 130d · This submission: 58d
Pathway characteristics
Standards-based clearance path.

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

All 9
Devices cleared under the same product code (MJC) and FDA review panel - the closest regulatory comparables to K993464.
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
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