Cleared Traditional

DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS (K973129) - FDA 510(k) Clearance

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

K973129 · Denver Biomaterials, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
208d
Days
Class 2
Risk

K973129 is an FDA 510(k) clearance for the DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS. Classified as Shunt, Peritoneal (product code KPM), Class II - Special Controls.

Submitted by Denver Biomaterials, Inc. (Evergreen, US). The FDA issued a Cleared decision on March 17, 1998 after a review of 208 days - an extended review cycle.

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: 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 Denver Biomaterials, Inc. devices

Submission Details

510(k) Number K973129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1997
Decision Date March 17, 1998
Days to Decision 208 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
78d slower than avg
Panel avg: 130d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - KPM Shunt, Peritoneal

All 7
Devices cleared under the same product code (KPM) and FDA review panel - the closest regulatory comparables to K973129.
Automatic Continuous Effusion Shunt (ACES) System ACES System
K231096 · Pleural Dynamics, Inc. · Aug 2023
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
DENVER PERITONEO-VENOUS SHUNT
K880401 · Codman & Shurtleff, Inc. · May 1988
CORDIS HAKIM ASCITES VALVE SYSTEM
K803258 · Cordis Corp. · Jan 1981