Cleared Traditional

K010596 - RUSCH BRONCHUS BLOCKER KIT

K010596 is an FDA 510(k) clearance for RUSCH BRONCHUS BLOCKER KIT, manufactured by Rusch Intl.. The device is a Class 2 Anesthesiology device with product code CBI cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K010596 · Rusch Intl. · Anesthesiology device
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Nov 2001
Decision
266d
Days
Class 2
Risk

K010596 is an FDA 510(k) clearance for the RUSCH BRONCHUS BLOCKER KIT. Classified as Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (product code CBI), Class II - Special Controls.

Submitted by Rusch Intl. (Jaffrey, US). The FDA issued a Cleared decision on November 21, 2001 after a review of 266 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.

View all Rusch Intl. devices

FDA 510(k) Submission Details - K010596

510(k) Number K010596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2001
Decision Date November 21, 2001
Days to Decision 266 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
126d slower than avg
Panel avg: 140d · This submission: 266d
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 K010596.
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
ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER
K002288 · Cook, Inc. · Nov 2000
BRONCHIAL BLOCKER
K962167 · Cook, Inc. · Aug 1997
KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE
K961977 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jul 1996