Cleared Traditional

K120334 - VIVA EB

K120334 is an FDA 510(k) clearance for VIVA EB, manufactured by Etview , Ltd.. The device is a Class 2 Anesthesiology device with product code CBI cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K120334 · Etview , Ltd. · Anesthesiology device
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Jun 2012
Decision
126d
Days
Class 2
Risk

K120334 is an FDA 510(k) clearance for the VIVA EB. Classified as Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (product code CBI), Class II - Special Controls.

Submitted by Etview , Ltd. (Binyamina, IL). The FDA issued a Cleared decision on June 8, 2012 after a review of 126 days - within the typical 510(k) review window.

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 Etview , Ltd. devices

FDA 510(k) Submission Details - K120334

510(k) Number K120334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2012
Decision Date June 08, 2012
Days to Decision 126 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
14d faster than avg
Panel avg: 140d · This submission: 126d
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 K120334.
RUSCH ENDOBRONCHIAL TUBES
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VIVASIGHT-DL SYSTEM
K123853 · Etview , Ltd. · Apr 2013
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DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM
K113576 · Etview , Ltd. · May 2012
CHARTIS CATHETER MODEL CHR-CA-12.0
K111522 · Pulmonx, Inc. · Sep 2011
SILBRONCHO DOUBLE LUMEN TUBE
K051522 · Fuji Systems Corp. · Aug 2005