Cleared Traditional

K002803 - THE O'NEIL STERILE FIELD URINARY CATHETER KIT

K002803 is an FDA 510(k) clearance for THE O'NEIL STERILE FIELD URINARY CATHET..., manufactured by Go Medical Industries Pty. , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FCM cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K002803 · Go Medical Industries Pty. , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
110d
Days
Class 2
Risk

K002803 is an FDA 510(k) clearance for the THE O'NEIL STERILE FIELD URINARY CATHETER KIT. Classified as Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (product code FCM), Class II - Special Controls.

Submitted by Go Medical Industries Pty. , Ltd. (Subiaco, Perth, AU). The FDA issued a Cleared decision on December 27, 2000 after a review of 110 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Go Medical Industries Pty. , Ltd. devices

FDA 510(k) Submission Details - K002803

510(k) Number K002803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2000
Decision Date December 27, 2000
Days to Decision 110 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
21d faster than avg
Panel avg: 131d · This submission: 110d
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 K002803.
AMSURE URETHRAL CATHETERIZATION TRAY
K030712 · Amsino International, Inc. · May 2003
RUSCH MMG/O'NEIL CATHETER
K010420 · Rusch, Inc. · May 2001
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
NHMC URETHRAL CATHETERIZATION TRAY
K962254 · National Healthcare Mfg. Corp. · Jul 1996