Cleared Traditional

K121849 - PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K121849 · Care Fusion · Anesthesiology device
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Oct 2012
Decision
115d
Days
Class 2
Risk

K121849 is an FDA 510(k) clearance for the PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER I.... 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 October 18, 2012 after a review of 115 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.

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Submission Details

510(k) Number K121849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2012
Decision Date October 18, 2012
Days to Decision 115 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 139d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.