Cleared Abbreviated

K003289 - BARDEX LATEX-FREE TEMPERATURE-SENSING F...

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

K003289 is the FDA 510(k) clearance for BARDEX LATEX-FREE TEMPERATURE-SENSING F... by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code EZL) cleared through the Abbreviated 510(k) pathway after a 77-day FDA review.

K003289 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Citech

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EZL Catheter, Retention Type, Balloon

All 58
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K003289.
BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON
K002612 · C.R. Bard, Inc. · Sep 2002
DRAINAGE CATHETER OR FOLEY CATHETER
K010006 · Applied Medical Resources Corp. · Jul 2001
MENTOR SELF-CATH PLUS
K003784 · Mentor Corp. · Mar 2001
BARD ALL-SILICONE 3-WAY FOLEY CATHETER
K002868 · C.R. Bard, Inc. · Dec 2000
RUSCH BRILLANT SILICONE FOLEY
K993063 · Rusch Intl. · Dec 1999
KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C
K990500 · The Kendal Co. · Sep 1999

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.