Cleared Traditional

K062061 - URASSIST (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K062061 · Preferred Medical Devices, Inc. · Gastroenterology & Urology device
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Oct 2006
Decision
77d
Days
Class 1
Risk

K062061 is an FDA 510(k) clearance for the URASSIST. Classified as Collector, Urine, Powered, Non Indwelling Catheter (product code NZU), Class I - General Controls.

Submitted by Preferred Medical Devices, Inc. (Kittery, US). The FDA issued a Cleared decision on October 5, 2006 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5250 - 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 Preferred Medical Devices, Inc. devices

Submission Details

510(k) Number K062061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2006
Decision Date October 05, 2006
Days to Decision 77 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
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NZU Collector, Urine, Powered, Non Indwelling Catheter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5250
Definition For The Non-invasive, Non-sterile Collection Of Urine And For Patients Unable To Void On Their Own Or Have Control Of Voiding. Often Patient Confined To The Bed Or A Wheelchair.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.