Vortran GO2VENT

FDA 510(k) K162968 · Vortran Medical Technology 1, Inc.

Substantially Equivalent

510(k) numberK162968

Submission

Device name
Vortran GO2VENT
Applicant
Vortran Medical Technology 1, Inc.
Sacramento, CA, US
Received
October 24, 2016
Decision date
April 10, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BTL – Ventilator, Emergency, Powered (Resuscitator)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5925
Specialty
Anesthesiology
Life-sustaining
Yes

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K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)BTL · Traditional Draegerwerk AG & CO Kgaa04/04/2025SE
K221634Oxymag - Transport and Emergency VentilatorBTL · Traditional Magnamed Tecnologia Medica S/A05/24/2023SE
K202219VORTRAN GO2VENT with PEEP ValveBTL · Traditional Vortran Medical Technology 1, Inc.02/11/2021SE
K193191MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagBTL · Traditional Weinmann Emergency Medical Technology GmbH + Co.…11/20/2020SE
K182956Puffin Lite Infant Resuscitation SystemBTL · Special International Biomedical01/18/2019SE
K173373SafeT T-Piece ResuscitatorBTL · Traditional Ventlab, LLC11/16/2018SE
K161420Moves SLCBTL · Traditional Thornhill Research, Inc.06/06/2017SE
K141595O-Two E700,O-TWO E600,O-TWO E500BTL · Traditional O-Two Medical Technologies, Inc.03/16/2015SE
K142096T-Piece ResuscitatorBTL · Traditional Mercury Medical10/17/2014SE
K140049Moves SLCBTL · Traditional Thornhill Research, Inc.05/29/2014SE

More from Thornhill Research, Inc.

510(k)DeviceDecision
K202219VORTRAN GO2VENT with PEEP ValveBTL · Traditional 02/11/2021SE
K182292VORTRAN APM-PlusCAP · Traditional 09/18/2019SE
K173914VORTRAN Cuff Inflator (VCI)BSK · Traditional 05/25/2018SE
K153733VORTRAN ManometerCAP · Traditional 09/16/2016SE
K103639Vortran Airway Pressure Monitor (Vapm)-Adult, Vortran Airway Pressure Monitor (Vapm)-…CAP · Traditional 09/15/2011SE
K073261Var MonitorBTL · Special 05/23/2008SE
K041473Var-Plus (Vortran Automatic Resuscitator), Model PCMBTL · Traditional 07/15/2004SE
K003684Percussiveneb, Model PN-2001NHJ · Special 02/23/2001SE
K001430Respirtech PRO-O2C, Model 2200 and Respirtech Pro, Model 2000BTL · Traditional 07/05/2000SE
K982016Piper Ippb Model 2055NHJ · Traditional 11/03/1998SE

Questions and answers

When was Vortran GO2VENT cleared by the FDA?

Vortran GO2VENT (K162968) received a 510(k) decision of Substantially Equivalent on April 10, 2017, 168 days after the submission was received.

What is the product code of K162968?

The FDA product code is BTL – Ventilator, Emergency, Powered (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5925.