Cleared Special

K003451 - DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K003451 · Denver Biomedicals, Inc. · Gastroenterology & Urology device
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Jan 2001
Decision
56d
Days
Class 2
Risk

K003451 is an FDA 510(k) clearance for the DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES .... Classified as Shunt, Peritoneal (product code KPM), Class II - Special Controls.

Submitted by Denver Biomedicals, Inc. (Golden, US). The FDA issued a Cleared decision on January 2, 2001 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5955 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Denver Biomedicals, Inc. devices

Submission Details

510(k) Number K003451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2000
Decision Date January 02, 2001
Days to Decision 56 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 130d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KPM Shunt, Peritoneal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5955
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.