Cleared Traditional

K122422 - PLEURX PLEURAL CATHETER SYSTEM PLEURX C...

K122422 is the FDA 510(k) clearance for PLEURX PLEURAL CATHETER SYSTEM PLEURX C... by Care Fusion. It is a Class 2 Gastroenterology & Urology device (product code PNG) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K122422 · Care Fusion · Gastroenterology & Urology device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 130d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
Devices cleared under the same product code (PNG) and FDA review panel - the closest regulatory comparables to K122422.
ASEPT Peritoneal Drainage System
K221779 · Pfm Medical, Inc. · May 2023
Aspira Peritoneal Drainage System
K212675 · Merit Medical Systems, Inc. · Dec 2021
PleurX Peritoneal Catheter System
K201155 · Care Fusion · Oct 2020
ASPIRA PERITONEAL DRAINAGE SYSTEM
K110396 · C.R. Bard, Inc. · May 2011
ASPIRA PERITONEAL DRAINAGE SYSTEM
K081288 · C.R. Bard, Inc. · Jul 2008