Cleared Traditional

K910022 - MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT

K910022 is an FDA 510(k) clearance for MMG/O'NEIL URINARY CATHETERIZATION SYST..., manufactured by Medical Marketing Group. The device is a Class 2 Gastroenterology & Urology device with product code FCM cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K910022 · Medical Marketing Group · Gastroenterology & Urology device
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Apr 1991
Decision
89d
Days
Class 2
Risk

K910022 is an FDA 510(k) clearance for the MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT. Classified as Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (product code FCM), Class II - Special Controls.

Submitted by Medical Marketing Group (Decatur, US). The FDA issued a Cleared decision on April 2, 1991 after a review of 89 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 Medical Marketing Group devices

FDA 510(k) Submission Details - K910022

510(k) Number K910022 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received January 03, 1991
Decision Date April 02, 1991
Days to Decision 89 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
42d faster than avg
Panel avg: 131d · This submission: 89d
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 39
Devices cleared under the same product code (FCM) and FDA review panel - the closest regulatory comparables to K910022.
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