Cleared Traditional

K071694 - COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX

K071694 is an FDA 510(k) clearance for COOPDECH ENDOBRONCHIAL BLOCKER TUBE, manufactured by Daiken Medical Co, Ltd.. The device is a Class 2 Anesthesiology device with product code CBI cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K071694 · Daiken Medical Co, Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
274d
Days
Class 2
Risk

K071694 is an FDA 510(k) clearance for the COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX. Classified as Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (product code CBI), Class II - Special Controls.

Submitted by Daiken Medical Co, Ltd. (Tokyo, JP). The FDA issued a Cleared decision on March 20, 2008 after a review of 274 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. 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.

FDA 510(k) Submission Details - K071694

510(k) Number K071694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2007
Decision Date March 20, 2008
Days to Decision 274 days
Submission Type Traditional
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
134d slower than avg
Panel avg: 140d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 32
Devices cleared under the same product code (CBI) and FDA review panel - the closest regulatory comparables to K071694.
COOPDECH ENDOBRONCHIAL BLOCKER TUBE
K093888 · Daiken Medical Co, Ltd. · Mar 2010
WELL LEAD ENDOBRONCHIAL TUBES
K092886 · Well Lead Instruments · Mar 2010
CHARTIS CATHETER
K083883 · Pulmonx, Inc. · Jun 2009
SILBRONCHO DOUBLE LUMEN TUBE
K051522 · Fuji Systems Corp. · Aug 2005
7.0 FR. ENDOBRONCHIAL BLOCKER
K021920 · Cook, Inc. · Aug 2002
TIP DEFLRCTING ENDOBRONCHIAL BLOCKER
K013865 · Cook, Inc. · Apr 2002