Cleared Traditional

RUSCH ENDOBRONCHIAL TUBES (K141888) - FDA 510(k) Clearance

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

K141888 · Teleflexmedical, Inc. · Anesthesiology device
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Apr 2015
Decision
275d
Days
Class 2
Risk

K141888 is an FDA 510(k) clearance for the RUSCH ENDOBRONCHIAL TUBES. Classified as Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (product code CBI), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on April 15, 2015 after a review of 275 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 Teleflexmedical, Inc. devices

Submission Details

510(k) Number K141888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2014
Decision Date April 15, 2015
Days to Decision 275 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
135d slower than avg
Panel avg: 140d · This submission: 275d
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 15
Devices cleared under the same product code (CBI) and FDA review panel - the closest regulatory comparables to K141888.
VivaSight-DL System
K181886 · Etview , Ltd. · Nov 2018
Sheridan Endobronchial Tubes
K180253 · Teleflex Medical · Nov 2018
5.0 Fr Arndt Endobronchial Blocker Set
K160542 · Cook Incorporated · Aug 2016
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