Cleared Special

K110396 - ASPIRA PERITONEAL DRAINAGE SYSTEM

K110396 is an FDA 510(k) clearance for ASPIRA PERITONEAL DRAINAGE SYSTEM, manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code PNG cleared through the Special 510(k) pathway after a 84-day FDA review.

K110396 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
84d
Days
Class 2
Risk

K110396 is an FDA 510(k) clearance for the ASPIRA PERITONEAL DRAINAGE SYSTEM. Classified as Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling (product code PNG), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on May 6, 2011 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - 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 - K110396

510(k) Number K110396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2011
Decision Date May 06, 2011
Days to Decision 84 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
47d faster than avg
Panel avg: 131d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

PNG Device Classification - Class 2, Special Controls

Product Code PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
Definition For Drainage Of Refractory Ascites With Long-term Occurrence From The Peritoneal Cavity.
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 - PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling

All 14
Devices cleared under the same product code (PNG) and FDA review panel - the closest regulatory comparables to K110396.
Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set
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PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER
K122422 · Care Fusion · Oct 2012
PLEURX PERITONEAL CATHETER SYSTEM
K113854 · Care Fusion · Mar 2012
ASEPT PERITONEAL DRAINAGE SYSTEM
K093796 · Pfm Medical, Inc. · Feb 2010
ASPIRA PERITONEAL DRAINAGE SYSTEM
K081288 · C.R. Bard, Inc. · Jul 2008
PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS
K051711 · Denver Biomedical, Inc. · Nov 2005
K110396 · ASPIRA PERITONEAL DRAINAGE SYSTEM
Download PDF FDA Summary C.R. Bard, Inc.