Cleared Traditional

K981612 - ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER

K981612 is an FDA 510(k) clearance for ALL SILICONE FOLEY CATHETER, manufactured by Rochester Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K981612 · Rochester Medical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
63d
Days
Class 2
Risk

K981612 is an FDA 510(k) clearance for the ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER.... Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Rochester Medical Corp. (Stewartville, US). The FDA issued a Cleared decision on July 8, 1998 after a review of 63 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 Rochester Medical Corp. devices

FDA 510(k) Submission Details - K981612

510(k) Number K981612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1998
Decision Date July 08, 1998
Days to Decision 63 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
68d faster than avg
Panel avg: 131d · This submission: 63d
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 92
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K981612.
MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER
K982970 · Mri Manufacturing and Research, Inc. · Oct 1998
EUROMEDICAL HAEMATURIA FOLEY CATHETER
K973076 · Unomedical Sdn Bhd · Sep 1998
URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0
K982626 · Medworks Corp. · Aug 1998
RUSCH SILICONE FOLEY CATHETER
K980870 · Rusch, Inc. · Jun 1998
ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER
K980919 · Fortune Medical Instrument Corp. · Mar 1998
RUSCH SIMPLASTIC COUNCILL TIP CATHETER
K974419 · Rusch, Inc. · Jan 1998