Cleared Traditional

K962167 - BRONCHIAL BLOCKER

K962167 is an FDA 510(k) clearance for BRONCHIAL BLOCKER, manufactured by Cook, Inc.. The device is a Class 2 Anesthesiology device with product code CBI cleared through the Traditional 510(k) pathway after a 450-day FDA review.

K962167 · Cook, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
450d
Days
Class 2
Risk

K962167 is an FDA 510(k) clearance for the BRONCHIAL 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 August 29, 1997 after a review of 450 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Cook, Inc. devices

FDA 510(k) Submission Details - K962167

510(k) Number K962167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1996
Decision Date August 29, 1997
Days to Decision 450 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
310d slower than avg
Panel avg: 140d · This submission: 450d
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 28
Devices cleared under the same product code (CBI) and FDA review panel - the closest regulatory comparables to K962167.
TIP DEFLRCTING ENDOBRONCHIAL BLOCKER
K013865 · Cook, Inc. · Apr 2002
RUSCH BRONCHUS BLOCKER KIT
K010596 · Rusch Intl. · Nov 2001
ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER
K002288 · Cook, Inc. · Nov 2000
KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE
K961977 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jul 1996
SIMS BLUE LINE ENDOBRONCHIAL TUBE
K953483 · Smiths Industries Medical Systems, Inc. · Oct 1995
SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE
K925615 · Sorin Biomedica, Fiat, USA, Inc. · Mar 1993