Cleared Traditional

K160450 - Pleurx Pleural Catheter System

K160450 is an FDA 510(k) clearance for Pleurx Pleural Catheter System, manufactured by Care Fusion. The device is a Class 2 Anesthesiology device with product code DWM cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K160450 · Care Fusion · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
256d
Days
Class 2
Risk

K160450 is an FDA 510(k) clearance for the Pleurx Pleural Catheter System. Classified as Apparatus, Suction, Patient Care (product code DWM), Class II - Special Controls.

Submitted by Care Fusion (Vernon Hills, US). The FDA issued a Cleared decision on October 31, 2016 after a review of 256 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.5050 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Care Fusion devices

FDA 510(k) Submission Details - K160450

510(k) Number K160450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2016
Decision Date October 31, 2016
Days to Decision 256 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 140d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWM Device Classification - Class 2, Special Controls

Product Code DWM Apparatus, Suction, Patient Care
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5050
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - DWM Apparatus, Suction, Patient Care

All 13
Devices cleared under the same product code (DWM) and FDA review panel - the closest regulatory comparables to K160450.
Passio Pump Drainage System
K201404 · Bearpac Medical · Nov 2020
Passio Pump Drainage System
K190292 · Bearpac Medical · Jul 2019
Rocket Indwelling Pleural Catheter (IPC) Insertion Kit
K163321 · Rocket Medical Plc · Aug 2017
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT
K141965 · Care Fusion · Jul 2015
ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B
K123033 · Rocket Medical Plc · Feb 2013
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE
K121849 · Care Fusion · Oct 2012