Cleared Traditional

K982970 - MRI'S ALL SILICONE IRRIGATION 3-WAY FOL...

K982970 is an FDA 510(k) clearance for MRI'S ALL SILICONE IRRIGATION 3-WAY FOL..., 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 64-day FDA review.

K982970 · Mri Manufacturing and Research, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
64d
Days
Class 2
Risk

K982970 is an FDA 510(k) clearance for the MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Mri Manufacturing and Research, Inc. (New Port Riche, US). The FDA issued a Cleared decision on October 28, 1998 after a review of 64 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 Mri Manufacturing and Research, Inc. devices

FDA 510(k) Submission Details - K982970

510(k) Number K982970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1998
Decision Date October 28, 1998
Days to Decision 64 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
66d faster than avg
Panel avg: 130d · This submission: 64d
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 K982970.
BARD ALL-SILICONE 3-WAY FOLEY CATHETER
K002868 · C.R. Bard, Inc. · Dec 2000
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
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