Cleared Traditional

K962167 - BRONCHIAL BLOCKER (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K962167 · Cook, Inc. · Anesthesiology device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
311d slower than avg
Panel avg: 139d · This submission: 450d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 33
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