Cleared Abbreviated

BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED) (K003289) - FDA 510(k) Clearance

Also marketed or referenced as:
BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU

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

K003289 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Jan 2001
Decision
77d
Days
Class 2
Risk

K003289 is an FDA 510(k) clearance for the BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED). Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on January 5, 2001 after a review of 77 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 K003289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2000
Decision Date January 05, 2001
Days to Decision 77 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

Device Classification

Product Code EZL Catheter, Retention Type, Balloon
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 Consultant

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Regulatory Peers - EZL Catheter, Retention Type, Balloon

All 127
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K003289.
Rusch SoftSimplastic Foley Catheters
K252537 · Teleflex Medical Sdn. Bhd. · Jan 2026
Silicone Urethral Catheter (Silicone Urethral Catheter)
K243011 · Guangdong Ecan Medical Co., Ltd. · Jun 2025
InnoCare Specialty Foley Catheter
K241424 · Innocare Urologics, LLC · Sep 2024
Rüsch Latex Gold Foley Catheter
K232469 · Teleflexmedical, Inc. · Aug 2024
TraumaGuard Intra-abdominal Pressure Sensing System
K240057 · Sentinel Medical Technologies, LLC · Apr 2024
Folysil Silicone Catheter
K233411 · Coloplast Corp. · Apr 2024

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.