Cleared Traditional

K162968 - VORTRAN GO2VENT

K162968 is an FDA 510(k) clearance for VORTRAN GO2VENT, manufactured by Vortran Medical Technology 1, Inc.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K162968 · Vortran Medical Technology 1, Inc. · Anesthesiology device
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Apr 2017
Decision
168d
Days
Class 2
Risk

K162968 is an FDA 510(k) clearance for the VORTRAN GO2VENT. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Vortran Medical Technology 1, Inc. (Sacramento, US). The FDA issued a Cleared decision on April 10, 2017 after a review of 168 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - 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 Vortran Medical Technology 1, Inc. devices

FDA 510(k) Submission Details - K162968

510(k) Number K162968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2016
Decision Date April 10, 2017
Days to Decision 168 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
28d slower than avg
Panel avg: 140d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTL Device Classification - Class 2, Special Controls

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
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 - BTL Ventilator, Emergency, Powered (resuscitator)

All 78
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K162968.
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T-PIECE RESUSCITATOR
K142096 · Mercury Medical · Oct 2014
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K140049 · Thornhill Research, Inc. · May 2014