Cleared Traditional

K152438 - ETView VivaSight-SL (TVT) system

K152438 is an FDA 510(k) clearance for ETView VivaSight-SL (TVT) system, manufactured by Etview , Ltd.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K152438 · Etview , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Etview , Ltd. devices

FDA 510(k) Submission Details - K152438

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 140d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

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 Consultant

Qsite
YORAM LEVY

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BTR Tube, Tracheal (w/wo Connector)

All 176
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K152438.
IRRIS (Infra-Red-Red Intubation System)
K171411 · A.R Guide IN Medical , Ltd. · Jan 2018
Frova Intubating Introducer
K161813 · William Cook Europe Aps · May 2017
Disposable Endotracheal tube, sterile, AccuCuff
K160694 · Tianjin Medis Medical Device Co., Ltd. · Apr 2017
Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye
K151381 · Covidien · Dec 2015
Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube
K150603 · Teleflexmedical, Inc. · Nov 2015
RHINOGUARD
K141747 · Davis Medical · Apr 2015