Cleared Special

K013865 - TIP DEFLRCTING ENDOBRONCHIAL BLOCKER

K013865 is the FDA 510(k) clearance for TIP DEFLRCTING ENDOBRONCHIAL BLOCKER by Cook, Inc.. It is a Class 2 Anesthesiology device (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)
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.

View all Cook, Inc. devices

Submission Details

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.

Device Classification

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 19
Devices cleared under the same product code (CBI) and FDA review panel - the closest regulatory comparables to K013865.
5.0 Fr Arndt Endobronchial Blocker Set
K160542 · Cook Incorporated · Aug 2016
RUSCH ENDOBRONCHIAL TUBES
K141888 · Teleflexmedical, Inc. · Apr 2015
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