Cleared Traditional

K973129 - DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS

K973129 is an FDA 510(k) clearance for DENVER ASCITES SHUNTS, manufactured by Denver Biomaterials, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPM cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K973129 · Denver Biomaterials, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K973129

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 131d · This submission: 208d
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 17
Devices cleared under the same product code (KPM) and FDA review panel - the closest regulatory comparables to K973129.
DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT
K011862 · Denver Biomedical, Inc. · Jul 2001
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
K011020 · Denver Biomedicals, Inc. · Jun 2001
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 PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
K962814 · Denver Biomaterials, Inc. · Apr 1997
DENVER(R) PERITONEO-SUBCLAVIAN SHUNT
K913728 · Denver Biomedicals, Inc. · Feb 1994
LEVEEN PERITINEO-VENOUS SHUNT
K901360 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
K973129 · DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS
Download PDF FDA Summary Denver Biomaterials, …