Cleared Traditional

K954752 - PEDIATRIC EUROPHYLIC FOLEY CATHETER

K954752 is the FDA 510(k) clearance for PEDIATRIC EUROPHYLIC FOLEY CATHETER by Regulatory & Marketing Services, Inc.. It is a Class 2 Gastroenterology & Urology device (product code EZL) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K954752 · Regulatory & Marketing Services, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
14d
Days
Class 2
Risk

K954752 is an FDA 510(k) clearance for the PEDIATRIC EUROPHYLIC FOLEY CATHETER. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Regulatory & Marketing Services, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on October 30, 1995 after a review of 14 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 Regulatory & Marketing Services, Inc. devices

Submission Details

510(k) Number K954752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1995
Decision Date October 30, 1995
Days to Decision 14 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 130d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - EZL Catheter, Retention Type, Balloon

All 46
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K954752.
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
BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED)
K003289 · C.R. Bard, Inc. · Jan 2001
BARD ALL-SILICONE 3-WAY FOLEY CATHETER
K002868 · C.R. Bard, Inc. · Dec 2000
EUROPHILIC SLIPPERY COATED FOLEY CATHETER
K944007 · Baxter Healthcare Corp · Jun 1995
SILICONE FOLEY CATHETER
K951106 · Cook Urological, Inc. · May 1995
SILASTIC BRAND FOLEY CATHETER
K951103 · C.R. Bard, Inc. · Apr 1995