Cleared Traditional

K903340 - STERILE URETHRAL CATHETER PROCEDURE KITS

K903340 is an FDA 510(k) clearance for STERILE URETHRAL CATHETER PROCEDURE KITS, manufactured by Superior Healthcare Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCM cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K903340 · Superior Healthcare Group, Inc. · Gastroenterology & Urology device
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Oct 1990
Decision
71d
Days
Class 2
Risk

K903340 is an FDA 510(k) clearance for the STERILE URETHRAL CATHETER PROCEDURE KITS. Classified as Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (product code FCM), Class II - Special Controls.

Submitted by Superior Healthcare Group, Inc. (Cumberland, US). The FDA issued a Cleared decision on October 4, 1990 after a review of 71 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 Superior Healthcare Group, Inc. devices

FDA 510(k) Submission Details - K903340

510(k) Number K903340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received July 25, 1990
Decision Date October 04, 1990
Days to Decision 71 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 131d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCM Device Classification - Class 2, Special Controls

Product Code FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
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 - FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)

All 37
Devices cleared under the same product code (FCM) and FDA review panel - the closest regulatory comparables to K903340.
FOLEY CATHETERIZATION TRAY
K942177 · Customed, Inc. · Sep 1994
MON-A-THERM FOLEY KIT
K923538 · Mallinckrodt Medical · May 1993
TOUCHLESS II INTERMITTENT CATHETER
K910653 · C.R. Bard, Inc. · May 1991
FOLEY CATHETER INSERTION TRAY (30CC)
K901180 · Orion Life Systems, Inc. · Jul 1990
CATHETER CARE TRAY
K901181 · Orion Life Systems, Inc. · Jul 1990
URETHRAL CATHETER TRAY (PVC)
K901183 · Orion Life Systems, Inc. · Jul 1990