Cleared Traditional

THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS (K011055) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011055 · Go Medical Industries Pty. , Ltd. · Gastroenterology & Urology device
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Jun 2001
Decision
61d
Days
Class 2
Risk

K011055 is an FDA 510(k) clearance for the THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS. 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 June 6, 2001 after a review of 61 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 Go Medical Industries Pty. , Ltd. devices

Submission Details

510(k) Number K011055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2001
Decision Date June 06, 2001
Days to Decision 61 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 130d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 59
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