Cleared Traditional

K945140 - URO-FLO (FDA 510(k) Clearance)

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

K945140 · Mallinckrodt Group, Inc. · Gastroenterology & Urology device
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Mar 1995
Decision
139d
Days
Class 2
Risk

K945140 is an FDA 510(k) clearance for the URO-FLO. Classified as System, Irrigation, Urological (product code LJH), Class II - Special Controls.

Submitted by Mallinckrodt Group, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 8, 1995 after a review of 139 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 Mallinckrodt Group, Inc. devices

Submission Details

510(k) Number K945140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1994
Decision Date March 08, 1995
Days to Decision 139 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
9d slower than avg
Panel avg: 130d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJH System, Irrigation, Urological
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.