VORTRAN GO2VENT with PEEP Valve
FDA 510(k) K202219 · Vortran Medical Technology 1, Inc.
510(k) numberK202219
Submission
- Device name
- VORTRAN GO2VENT with PEEP Valve
- Applicant
- Vortran Medical Technology 1, Inc.
Sacramento, CA, US - Received
- August 6, 2020
- Decision date
- February 11, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)BTL · Traditional | Draegerwerk AG & CO Kgaa | 04/04/2025SE |
| K221634 | Oxymag - Transport and Emergency VentilatorBTL · Traditional | Magnamed Tecnologia Medica S/A | 05/24/2023SE |
| K193191 | MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagBTL · Traditional | Weinmann Emergency Medical Technology GmbH + Co.… | 11/20/2020SE |
| K182956 | Puffin Lite Infant Resuscitation SystemBTL · Special | International Biomedical | 01/18/2019SE |
| K173373 | SafeT T-Piece ResuscitatorBTL · Traditional | Ventlab, LLC | 11/16/2018SE |
| K161420 | Moves SLCBTL · Traditional | Thornhill Research, Inc. | 06/06/2017SE |
| K162968 | Vortran GO2VENTBTL · Traditional | Vortran Medical Technology 1, Inc. | 04/10/2017SE |
| K141595 | O-Two E700,O-TWO E600,O-TWO E500BTL · Traditional | O-Two Medical Technologies, Inc. | 03/16/2015SE |
| K142096 | T-Piece ResuscitatorBTL · Traditional | Mercury Medical | 10/17/2014SE |
| K140049 | Moves SLCBTL · Traditional | Thornhill Research, Inc. | 05/29/2014SE |
More from Thornhill Research, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K182292 | VORTRAN APM-PlusCAP · Traditional | 09/18/2019SE |
| K173914 | VORTRAN Cuff Inflator (VCI)BSK · Traditional | 05/25/2018SE |
| K162968 | Vortran GO2VENTBTL · Traditional | 04/10/2017SE |
| K153733 | VORTRAN ManometerCAP · Traditional | 09/16/2016SE |
| K103639 | Vortran Airway Pressure Monitor (Vapm)-Adult, Vortran Airway Pressure Monitor (Vapm)-…CAP · Traditional | 09/15/2011SE |
| K073261 | Var MonitorBTL · Special | 05/23/2008SE |
| K041473 | Var-Plus (Vortran Automatic Resuscitator), Model PCMBTL · Traditional | 07/15/2004SE |
| K003684 | Percussiveneb, Model PN-2001NHJ · Special | 02/23/2001SE |
| K001430 | Respirtech PRO-O2C, Model 2200 and Respirtech Pro, Model 2000BTL · Traditional | 07/05/2000SE |
| K982016 | Piper Ippb Model 2055NHJ · Traditional | 11/03/1998SE |
Questions and answers
When was VORTRAN GO2VENT with PEEP Valve cleared by the FDA?
VORTRAN GO2VENT with PEEP Valve (K202219) received a 510(k) decision of Substantially Equivalent on February 11, 2021, 189 days after the submission was received.
What is the product code of K202219?
The FDA product code is BTL – Ventilator, Emergency, Powered (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5925.