Cleared Traditional

K113854 - PLEURX PERITONEAL CATHETER SYSTEM

K113854 is an FDA 510(k) clearance for PLEURX PERITONEAL CATHETER SYSTEM, manufactured by Care Fusion. The device is a Class 2 Gastroenterology & Urology device with product code PNG cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K113854 · Care Fusion · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
81d
Days
Class 2
Risk

K113854 is an FDA 510(k) clearance for the PLEURX PERITONEAL CATHETER SYSTEM. Classified as Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling (product code PNG), Class II - Special Controls.

Submitted by Care Fusion (Waukegan, US). The FDA issued a Cleared decision on March 19, 2012 after a review of 81 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.

View all Care Fusion devices

FDA 510(k) Submission Details - K113854

510(k) Number K113854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received December 29, 2011
Decision Date March 19, 2012
Days to Decision 81 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
50d faster than avg
Panel avg: 131d · This submission: 81d
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 13
Devices cleared under the same product code (PNG) and FDA review panel - the closest regulatory comparables to K113854.
PleurX Peritoneal Catheter System
K160437 · Care Fusion · Nov 2016
Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set
K152105 · Rocket Medical Plc · Mar 2016
PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER
K122422 · Care Fusion · Oct 2012
ASPIRA PERITONEAL DRAINAGE SYSTEM
K110396 · C.R. Bard, Inc. · May 2011
ASEPT PERITONEAL DRAINAGE SYSTEM
K093796 · Pfm Medical, Inc. · Feb 2010
ASPIRA PERITONEAL DRAINAGE SYSTEM
K081288 · C.R. Bard, Inc. · Jul 2008