Cleared Traditional

K160437 - PleurX Peritoneal Catheter System

K160437 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 260-day FDA review.

K160437 · Care Fusion · Gastroenterology & Urology device
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Nov 2016
Decision
260d
Days
Class 2
Risk

K160437 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 (Vernon Hills, US). The FDA issued a Cleared decision on November 3, 2016 after a review of 260 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Care Fusion devices

FDA 510(k) Submission Details - K160437

510(k) Number K160437 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received February 17, 2016
Decision Date November 03, 2016
Days to Decision 260 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
130d slower than avg
Panel avg: 130d · This submission: 260d
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 K160437.
Aspira Peritoneal Drainage System
K212675 · Merit Medical Systems, Inc. · Dec 2021
PleurX Peritoneal Catheter System
K201155 · Care Fusion · Oct 2020
Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
K162457 · Rocket Medical Plc · 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
PLEURX PERITONEAL CATHETER SYSTEM
K113854 · Care Fusion · Mar 2012