Cleared Traditional

K984084 - BARDEX LUBRI-SIL FOLEY CATHETER

K984084 is an FDA 510(k) clearance for BARDEX LUBRI-SIL FOLEY CATHETER, manufactured by Bard Medical Div.. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K984084 · Bard Medical Div. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
77d
Days
Class 2
Risk

K984084 is an FDA 510(k) clearance for the BARDEX LUBRI-SIL FOLEY CATHETER. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Bard Medical Div. (Covington, US). The FDA issued a Cleared decision on February 1, 1999 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 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 Bard Medical Div. devices

FDA 510(k) Submission Details - K984084

510(k) Number K984084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1998
Decision Date February 01, 1999
Days to Decision 77 days
Submission Type Traditional
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
54d faster than avg
Panel avg: 131d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZL Device Classification - Class 2, Special Controls

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 Peers - EZL Catheter, Retention Type, Balloon

All 106
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K984084.
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
OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818
K990509 · Implemed, Inc. · May 1999
MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER
K982970 · Mri Manufacturing and Research, Inc. · Oct 1998
EUROMEDICAL HAEMATURIA FOLEY CATHETER
K973076 · Unomedical Sdn Bhd · Sep 1998
URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0
K982626 · Medworks Corp. · Aug 1998