Cleared Traditional

K024010 - DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER

K024010 is an FDA 510(k) clearance for DOVER SILVER HYDROGEL COATED SILICONE F..., manufactured by The Kendall Company Div. of Tyco Healthcare Group. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K024010 · The Kendall Company Div. of Tyco Healthcare Group · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
189d
Days
Class 2
Risk

K024010 is an FDA 510(k) clearance for the DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by The Kendall Company Div. of Tyco Healthcare Group (Mansfield, US). The FDA issued a Cleared decision on June 11, 2003 after a review of 189 days - an extended review 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: 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.

FDA 510(k) Submission Details - K024010

510(k) Number K024010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2002
Decision Date June 11, 2003
Days to Decision 189 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
58d slower than avg
Panel avg: 131d · This submission: 189d
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 128
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K024010.
OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218
K033830 · Opticon Medical, Inc. · Jan 2004
AMSURE FOLEY CATHETER
K030120 · Amsino International, Inc. · Oct 2003
VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
K031748 · Vitalcare Group, Inc. · Aug 2003
PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND
K030813 · Primary Care Solutions, Inc. · May 2003
VITALCARE FOLEY CATHETER
K021939 · Vitalcare, Inc. · Apr 2003
OPTION-VF URINARY CATHETER, FV14218
K023090 · Opticon Medical, Inc. · Mar 2003
K024010 · DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER
Download PDF FDA Summary The Kendall Company D…