Cleared Traditional

K944673 - MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE

K944673 is an FDA 510(k) clearance for MRI'S ALL SILICONE FOLEY CATHETER TEMPE..., manufactured by Regulatory & Marketing Services, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 566-day FDA review.

K944673 · Regulatory & Marketing Services, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
566d
Days
Class 2
Risk

K944673 is an FDA 510(k) clearance for the MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE. 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 April 10, 1996 after a review of 566 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 Regulatory & Marketing Services, Inc. devices

FDA 510(k) Submission Details - K944673

510(k) Number K944673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1994
Decision Date April 10, 1996
Days to Decision 566 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
435d slower than avg
Panel avg: 131d · This submission: 566d
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 77
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K944673.
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
PEDIATRIC EUROPHYLIC FOLEY CATHETER
K954752 · Regulatory & Marketing Services, Inc. · Oct 1995
EUROPHILIC SLIPPERY COATED FOLEY CATHETER
K944007 · Baxter Healthcare Corp · Jun 1995
SILICONE FOLEY CATHETER
K951106 · Cook Urological, Inc. · May 1995