Cleared Traditional

K081288 - ASPIRA PERITONEAL DRAINAGE SYSTEM

K081288 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 Traditional 510(k) pathway after a 72-day FDA review.

K081288 · 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
Jul 2008
Decision
72d
Days
Class 2
Risk

K081288 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 July 18, 2008 after a review of 72 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K081288

510(k) Number K081288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2008
Decision Date July 18, 2008
Days to Decision 72 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
59d faster than avg
Panel avg: 131d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K081288.
PLEURX PERITONEAL CATHETER SYSTEM
K113854 · Care Fusion · Mar 2012
ASPIRA PERITONEAL DRAINAGE SYSTEM
K110396 · C.R. Bard, Inc. · May 2011
ASEPT PERITONEAL DRAINAGE SYSTEM
K093796 · Pfm Medical, Inc. · Feb 2010
PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS
K051711 · Denver Biomedical, Inc. · Nov 2005
K081288 · ASPIRA PERITONEAL DRAINAGE SYSTEM
Download PDF FDA Summary C.R. Bard, Inc.