Cleared Traditional

K112831 - PLEURX PLEURAL CATHETER SYSTEMS

K112831 is an FDA 510(k) clearance for PLEURX PLEURAL CATHETER SYSTEMS, 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 141-day FDA review.

K112831 · Care Fusion · Anesthesiology device
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Feb 2012
Decision
141d
Days
Class 2
Risk

K112831 is an FDA 510(k) clearance for the PLEURX PLEURAL CATHETER SYSTEMS. Classified as Apparatus, Suction, Patient Care (product code DWM), Class II - Special Controls.

Submitted by Care Fusion (Waukegan, US). The FDA issued a Cleared decision on February 16, 2012 after a review of 141 days - within the typical 510(k) review window.

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 - K112831

510(k) Number K112831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2011
Decision Date February 16, 2012
Days to Decision 141 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
1d slower than avg
Panel avg: 140d · This submission: 141d
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 K112831.
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
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PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE
K121849 · Care Fusion · Oct 2012
ASPIRA PLEURAL DRAINAGE SYSTEM
K110409 · C.R. Bard, Inc. · May 2011
ASEPT PLEURAL DRAINAGE SYSTEM
K093307 · Pfm Medical, Inc. · Nov 2009
ASPIRA PLEURAL DRAINAGE SYSTEM
K071095 · Bard Access Systems, Inc. · May 2007