Cleared Traditional

K010420 - RUSCH MMG/O'NEIL CATHETER

K010420 is an FDA 510(k) clearance for RUSCH MMG/O'NEIL CATHETER, manufactured by Rusch, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCM cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K010420 · Rusch, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
86d
Days
Class 2
Risk

K010420 is an FDA 510(k) clearance for the RUSCH MMG/O'NEIL CATHETER. Classified as Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (product code FCM), Class II - Special Controls.

Submitted by Rusch, Inc. (Duluth, US). The FDA issued a Cleared decision on May 9, 2001 after a review of 86 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 Rusch, Inc. devices

FDA 510(k) Submission Details - K010420

510(k) Number K010420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2001
Decision Date May 09, 2001
Days to Decision 86 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
44d faster than avg
Panel avg: 130d · This submission: 86d
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 29
Devices cleared under the same product code (FCM) and FDA review panel - the closest regulatory comparables to K010420.
AMSELF CLOSED CATHETERIZATION SYSTEM
K082831 · Amsino International, Inc. · Oct 2008
AMSURE FOLEY INSERTION TRAY
K030664 · Amsino International, Inc. · May 2003
AMSURE URETHRAL CATHETERIZATION TRAY
K030712 · Amsino International, Inc. · May 2003
MENTOR SELF-CATH CLOSED SYSTEM
K003873 · Mentor Corp. · Mar 2001
SELF CATH SET/SAFETY CATH
K983010 · Rusch Intl. · Feb 1999
RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET
K963993 · Rusch, Inc. · Dec 1996