Cleared Traditional

K913728 - DENVER(R) PERITONEO-SUBCLAVIAN SHUNT

K913728 is an FDA 510(k) clearance for DENVER PERITONEO-SUBCLAVIAN SHUNT, manufactured by Denver Biomedicals, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPM cleared through the Traditional 510(k) pathway after a 913-day FDA review.

K913728 · Denver Biomedicals, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
913d
Days
Class 2
Risk

K913728 is an FDA 510(k) clearance for the DENVER(R) PERITONEO-SUBCLAVIAN SHUNT. Classified as Shunt, Peritoneal (product code KPM), Class II - Special Controls.

Submitted by Denver Biomedicals, Inc. (Evergreen, US). The FDA issued a Cleared decision on February 18, 1994 after a review of 913 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5955 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

FDA 510(k) Submission Details - K913728

510(k) Number K913728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1991
Decision Date February 18, 1994
Days to Decision 913 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
782d slower than avg
Panel avg: 131d · This submission: 913d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPM Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KPM Shunt, Peritoneal

All 14
Devices cleared under the same product code (KPM) and FDA review panel - the closest regulatory comparables to K913728.
DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T
K003451 · Denver Biomedicals, Inc. · Jan 2001
DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS
K973129 · Denver Biomaterials, Inc. · Mar 1998
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
K962814 · Denver Biomaterials, Inc. · Apr 1997
LEVEEN PERITINEO-VENOUS SHUNT
K901360 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
DENVER PERITONEO-VENUS SHUNT
K894756 · Codman & Shurtleff, Inc. · Sep 1989
DENVER PLEURO-PERITONEAL SHUNT
K880570 · Codman & Shurtleff, Inc. · Jun 1988