Cleared Traditional

K944676 - MRI'S ALL SILICONE FOLEY CATHETER

K944676 is an FDA 510(k) clearance for MRI'S ALL SILICONE FOLEY CATHETER, manufactured by Mri Manufacturing and Research, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 561-day FDA review.

K944676 · Mri Manufacturing and Research, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
561d
Days
Class 2
Risk

K944676 is an FDA 510(k) clearance for the MRI'S ALL SILICONE FOLEY CATHETER. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Mri Manufacturing and Research, Inc. (Tuscon, US). The FDA issued a Cleared decision on April 5, 1996 after a review of 561 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Mri Manufacturing and Research, Inc. devices

FDA 510(k) Submission Details - K944676

510(k) Number K944676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1994
Decision Date April 05, 1996
Days to Decision 561 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
431d slower than avg
Panel avg: 130d · This submission: 561d
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 64
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K944676.
RUSCH BRILLANT SILICONE FOLEY CATHETER
K972184 · Rusch Intl. · Jan 1998
RUSCH BRILLANT BALLOON CATHETER
K971643 · Rusch Intl. · Oct 1997
SYMPACATH HYDROGEL COATED FOLEY
K964575 · Rusch Intl. · Feb 1997
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