Cleared Special

K012235 - DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER

K012235 is an FDA 510(k) clearance for DENVER PLEURAL EFFUSION SHUNT AND DENVE..., manufactured by Denver Biomedical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPM cleared through the Special 510(k) pathway after a 79-day FDA review.

K012235 · Denver Biomedical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
79d
Days
Class 2
Risk

K012235 is an FDA 510(k) clearance for the DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL.... Classified as Shunt, Peritoneal (product code KPM), Class II - Special Controls.

Submitted by Denver Biomedical, Inc. (Golden, US). The FDA issued a Cleared decision on October 4, 2001 after a review of 79 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.

FDA 510(k) Submission Details - K012235

510(k) Number K012235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2001
Decision Date October 04, 2001
Days to Decision 79 days
Submission Type Special
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
52d faster than avg
Panel avg: 131d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

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 13
Devices cleared under the same product code (KPM) and FDA review panel - the closest regulatory comparables to K012235.
Automatic Continuous Effusion Shunt (ACES) System ACES System
K231096 · Pleural Dynamics, Inc. · Aug 2023
BD Curve Ascites Shunt
K170405 · Care Fusion · Nov 2017
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 ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS
K973129 · Denver Biomaterials, Inc. · Mar 1998