Cleared Traditional

K150042 - PleuraFlow System

K150042 is an FDA 510(k) clearance for PleuraFlow System, manufactured by Clearflow, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OTK cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K150042 · Clearflow, Inc. · General & Plastic Surgery device
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Jun 2015
Decision
144d
Days
Class 2
Risk

K150042 is an FDA 510(k) clearance for the PleuraFlow System. Classified as Wound Drain Catheter System (product code OTK), Class II - Special Controls.

Submitted by Clearflow, Inc. (Anaheim, US). The FDA issued a Cleared decision on June 2, 2015 after a review of 144 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Clearflow, Inc. devices

FDA 510(k) Submission Details - K150042

510(k) Number K150042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2015
Decision Date June 02, 2015
Days to Decision 144 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 115d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OTK Device Classification - Class 2, Special Controls

Product Code OTK Wound Drain Catheter System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
Definition For Use As An Adjunctive Device During Open Surgical Procedures In Order To Prevent Fluid Accumulation Within The Operative Site After Closure Of The Surgical Wound. The Device Is Indicated For Use In Thoracic Surgical Procedures.
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 General & Plastic Surgery devices follow this clearance model.