Cleared Traditional

K093565 - PLEURAFLOW CATHETER SYSTEM

K093565 is an FDA 510(k) clearance for PLEURAFLOW CATHETER SYSTEM, manufactured by Clear Catheter Systems. The device is a Class 2 General & Plastic Surgery device with product code OTK cleared through the Traditional 510(k) pathway after a 380-day FDA review.

K093565 · Clear Catheter Systems · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
380d
Days
Class 2
Risk

K093565 is an FDA 510(k) clearance for the PLEURAFLOW CATHETER SYSTEM. Classified as Wound Drain Catheter System (product code OTK), Class II - Special Controls.

Submitted by Clear Catheter Systems (Alexandria, US). The FDA issued a Cleared decision on December 3, 2010 after a review of 380 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Clear Catheter Systems devices

FDA 510(k) Submission Details - K093565

510(k) Number K093565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2009
Decision Date December 03, 2010
Days to Decision 380 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
265d slower than avg
Panel avg: 115d · This submission: 380d
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.