Uni-Vent Model 730AEV (Automatic Emergency Ventilator)
FDA 510(k) K032386 · Impact Instrumentation, Inc.
510(k) numberK032386
Submission
- Device name
- Uni-Vent Model 730AEV (Automatic Emergency Ventilator)
- Applicant
- Impact Instrumentation, Inc.
West Caldwell, NJ, US - Received
- August 4, 2003
- Decision date
- March 26, 2004
- 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 |
| K202219 | VORTRAN GO2VENT with PEEP ValveBTL · Traditional | Vortran Medical Technology 1, Inc. | 02/11/2021SE |
| 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 |
More from Mercury Medical
| 510(k) | Device | Decision |
|---|---|---|
| K133196 | Impact Model 323 AspiratorJCX · Traditional | 03/10/2014SE |
| K111473 | Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorCBK · Traditional | 02/16/2012SE |
| K103318 | Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorCBK · Traditional | 04/07/2011SE |
| K091238 | UNI-VENT-731 Series Ventilators, Model 731EMV+CBK · Traditional | 08/13/2009SE |
| K071526 | Uni-Vent 731 Series Ventilators, Model 731, 731EMVCBK · Traditional | 12/10/2008SE |
| K051476 | Uni-Vent Model 73XBTL · Traditional | 10/28/2005SE |
| K022062 | Impact, Universal Single-Limb, Ventilator Circuit, Model 820-0099-00MOD · Abbreviated | 05/06/2003SE |
| K951423 | Aspirator, Continuous & Programmable IntermittentBTA · Traditional | 04/18/1995SE |
| K941096 | Electric Vacum PumpBTA · Traditional | 01/05/1995SE |
| K931473 | Impact Model 753BTL · Traditional | 12/30/1994SE |
Questions and answers
When was Uni-Vent Model 730AEV (Automatic Emergency Ventilator) cleared by the FDA?
Uni-Vent Model 730AEV (Automatic Emergency Ventilator) (K032386) received a 510(k) decision of Substantially Equivalent on March 26, 2004, 235 days after the submission was received.
What is the product code of K032386?
The FDA product code is BTL – Ventilator, Emergency, Powered (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5925.