Cleared Traditional

K122422 - PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER

K122422 is an FDA 510(k) clearance for PLEURX PLEURAL CATHETER SYSTEM PLEURX C..., 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 76-day FDA review.

K122422 · Care Fusion · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
76d
Days
Class 2
Risk

K122422 is an FDA 510(k) clearance for the PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED.... 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 October 24, 2012 after a review of 76 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 - K122422

510(k) Number K122422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received August 09, 2012
Decision Date October 24, 2012
Days to Decision 76 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
55d faster than avg
Panel avg: 131d · This submission: 76d
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 K122422.
Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
K162457 · Rocket Medical Plc · Nov 2016
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 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