Cleared Traditional

K141965 - PLEURX PLEURAL CATHETER SYSTEM

K141965 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 346-day FDA review.

K141965 · Care Fusion · Anesthesiology device
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Jul 2015
Decision
346d
Days
Class 2
Risk

K141965 is an FDA 510(k) clearance for the PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT. 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 July 2, 2015 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K141965

510(k) Number K141965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2014
Decision Date July 02, 2015
Days to Decision 346 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
206d slower than avg
Panel avg: 140d · This submission: 346d
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 K141965.
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
K160450 · Care Fusion · Oct 2016
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
PLEURX PLEURAL CATHETER SYSTEMS
K112831 · Care Fusion · Feb 2012