Cleared Special

K013865 - TIP DEFLRCTING ENDOBRONCHIAL BLOCKER

K013865 is an FDA 510(k) clearance for TIP DEFLRCTING ENDOBRONCHIAL BLOCKER, manufactured by Cook, Inc.. The device is a Class 2 Anesthesiology device with product code CBI cleared through the Special 510(k) pathway after a 152-day FDA review.

K013865 · Cook, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
152d
Days
Class 2
Risk

K013865 is an FDA 510(k) clearance for the TIP DEFLRCTING ENDOBRONCHIAL BLOCKER. Classified as Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (product code CBI), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on April 22, 2002 after a review of 152 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5740 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K013865

510(k) Number K013865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2001
Decision Date April 22, 2002
Days to Decision 152 days
Submission Type Special
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
12d slower than avg
Panel avg: 140d · This submission: 152d
Pathway characteristics
Modification to existing cleared device.

CBI Device Classification - Class 2, Special Controls

Product Code CBI Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5740
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 - CBI Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)

All 33
Devices cleared under the same product code (CBI) and FDA review panel - the closest regulatory comparables to K013865.
COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX
K071694 · Daiken Medical Co, Ltd. · Mar 2008
SILBRONCHO DOUBLE LUMEN TUBE
K051522 · Fuji Systems Corp. · Aug 2005
7.0 FR. ENDOBRONCHIAL BLOCKER
K021920 · Cook, Inc. · Aug 2002
RUSCH BRONCHUS BLOCKER KIT
K010596 · Rusch Intl. · Nov 2001
ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER
K002288 · Cook, Inc. · Nov 2000
BRONCHIAL BLOCKER
K962167 · Cook, Inc. · Aug 1997
K013865 · TIP DEFLRCTING ENDOBRONCHIAL BLOCKER
Download PDF FDA Summary Cook, Inc.