BTL · Ventilator, Emergency, Powered (Resuscitator)
Anesthesiology · 21 CFR 868.5925 · Class 2
Overview
| Product Code | BTL |
|---|---|
| Device Name | Ventilator, Emergency, Powered (Resuscitator) |
| Regulation | 21 CFR 868.5925 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
Identification
A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 100)
Showing 20 most recent of 100 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) | Draegerwerk AG & CO Kgaa | Apr 4, 2025 | SESE |
| K221634 | Oxymag - Transport and Emergency Ventilator | Magnamed Tecnologia Medica S/A | May 24, 2023 | SESE |
| K202219 | VORTRAN GO2VENT with PEEP Valve | Vortran Medical Technology 1, Inc. | Feb 11, 2021 | SESE |
| K193191 | MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag | Weinmann Emergency Medical Technology GmbH + Co. KG | Nov 20, 2020 | SESE |
| K182956 | Puffin Lite Infant Resuscitation System | International Biomedical | Jan 18, 2019 | SESE |
| K173373 | SafeT T-Piece Resuscitator | Ventlab, LLC | Nov 16, 2018 | SESE |
| K161420 | MOVES SLC | Thornhill Research, Inc. | Jun 6, 2017 | SESE |
| K162968 | VORTRAN GO2VENT | Vortran Medical Technology 1, Inc. | Apr 10, 2017 | SESE |
| K141595 | O-TWO E700,O-TWO E600,O-TWO E500 | O-Two Medical Technologies, Inc. | Mar 16, 2015 | SESE |
| K142096 | T-PIECE RESUSCITATOR | Mercury Medical | Oct 17, 2014 | SESE |
| K140049 | MOVES SLC | Thornhill Research, Inc. | May 29, 2014 | SESE |
| K140707 | LIFEBORNE INFANT RESUSCITATOR | International Biomedical | May 28, 2014 | SESE |
| K131098 | EMERGENCY PORTABLE VENTILATOR | Allied Healthcare Products, Inc. | Apr 9, 2014 | SESE |
| K132021 | AHP 300, EMERGENCY PORTABLE VENTILATOR | Allied Healthcare Products, Inc. | Apr 2, 2014 | SESE |
| K132759 | VENTRAIN | Dolphys Medical B.V. | Mar 26, 2014 | SESE |
| K131877 | SAVE II, SAVE II BASIC | Automedx, Inc. | Mar 21, 2014 | SESE |
| K123957 | PNEUPAC PARAPAC PLUS | Smiths Medical International , Ltd. | Sep 16, 2013 | SESE |
| K112783 | MANUJET III | VBM Medizintechnik GmbH | Dec 22, 2011 | SESE |
| K102542 | RESUSCI FLOW; RESUSCI FLOW 104 | Atom Medical Corporation | Apr 6, 2011 | SESE |
| K093862 | CAREVENT HANDHELD CPAP SYSTEM | O-Two Medical Technologies, Inc. | May 6, 2010 | SESE |
Top Applicants
- Allied Healthcare Products, Inc. — 9 clearances
- Life Support Products, Inc. — 8 clearances
- Pneupac , Ltd. — 8 clearances
- O-Two Systems Intl., Inc. — 7 clearances
- Vortran Medical Technology 1, Inc. — 6 clearances
