Cleared Traditional

K152438 - ETView VivaSight-SL (TVT) system (FDA 510(k) Clearance)

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

K152438 · Etview , Ltd. · Anesthesiology device
Feb 2016
Decision
182d
Days
Class 2
Risk

K152438 is an FDA 510(k) clearance for the ETView VivaSight-SL (TVT) system. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Etview , Ltd. (Misgav Business Park, IL). The FDA issued a Cleared decision on February 25, 2016 after a review of 182 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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.

Submission Details

510(k) Number K152438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2015
Decision Date February 25, 2016
Days to Decision 182 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 225d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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 - BTR Tube, Tracheal (w/wo Connector)

All 8
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K152438.
Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)
K250173 · Covidien, LLC · Oct 2025
Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced
K243785 · Covidien, LLC · Sep 2025
AeroJet Ventilation Catheter
K243579 · Pipeline Medical Products, LLC · Aug 2025
Frova Intubating Introducer (C-CAE-14.0-70-FII)
K251499 · William Cook Europe Aps · Jun 2025
ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U)
K250243 · Flexicare Medical Limited. · May 2025
LMA Fastrach ETT SU
K242495 · Teleflex Medical · Apr 2025