Product code BTL
- Device name
- Ventilator, Emergency, Powered (Resuscitator)
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5925
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) | Draegerwerk AG & CO Kgaa | 2025-04-04 |
| K221634 | Oxymag - Transport and Emergency Ventilator | Magnamed Tecnologia Medica S/A | 2023-05-24 |
| K202219 | VORTRAN GO2VENT with PEEP Valve | Vortran Medical Technology 1, Inc. | 2021-02-11 |
| K193191 | MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag | Weinmann Emergency Medical Technology GmbH + Co. KG | 2020-11-20 |
| K182956 | Puffin Lite Infant Resuscitation System | International Biomedical | 2019-01-18 |
| K173373 | SafeT T-Piece Resuscitator | Ventlab, LLC | 2018-11-16 |
| K161420 | MOVES SLC | Thornhill Research, Inc. | 2017-06-06 |
| K162968 | VORTRAN GO2VENT | Vortran Medical Technology 1, Inc. | 2017-04-10 |
| K141595 | O-TWO E700,O-TWO E600,O-TWO E500 | O-Two Medical Technologies, Inc. | 2015-03-16 |
| K142096 | T-PIECE RESUSCITATOR | Mercury Medical | 2014-10-17 |
| K140049 | MOVES SLC | Thornhill Research, Inc. | 2014-05-29 |
| K140707 | LIFEBORNE INFANT RESUSCITATOR | International Biomedical | 2014-05-28 |
| K131098 | EMERGENCY PORTABLE VENTILATOR | Allied Healthcare Products, Inc. | 2014-04-09 |
| K132021 | AHP 300, EMERGENCY PORTABLE VENTILATOR | Allied Healthcare Products, Inc. | 2014-04-02 |
| K132759 | VENTRAIN | Dolphys Medical B.V. | 2014-03-26 |
| K131877 | SAVE II, SAVE II BASIC | Automedx, Inc. | 2014-03-21 |
| K123957 | PNEUPAC PARAPAC PLUS | Smiths Medical International , Ltd. | 2013-09-16 |
| K112783 | MANUJET III | VBM Medizintechnik GmbH | 2011-12-22 |
| K102542 | RESUSCI FLOW; RESUSCI FLOW 104 | Atom Medical Corporation | 2011-04-06 |
| K093862 | CAREVENT HANDHELD CPAP SYSTEM | O-Two Medical Technologies, Inc. | 2010-05-06 |
| K093913 | MERCURY MEDICAL T-PIECE RESUSCITATOR | Mercury Medical, Inc. | 2010-04-06 |
| K093261 | MOVES | Thornhill Research, Inc. | 2010-03-26 |
| K092085 | ISPIRA RESUSCITATION UNIT | Neoforce Group, Inc. | 2009-10-07 |
| K090356 | EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 | Allied Healthcare Products, Inc. | 2009-05-20 |
| K083507 | BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS | Allied Healthcare Products, Inc. | 2009-05-18 |
| K083385 | MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B | Allied Healthcare Products, Inc. | 2009-05-14 |
| K081330 | CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) | O-Two Medical Technologies, Inc. | 2009-03-06 |
| K080063 | MASS CASUALTY VENTILATOR, MODEL MCV100 | Allied Healthcare Products, Inc. | 2008-08-15 |
| K080692 | MACS CPAP SYSTEM | Airon Corporation | 2008-06-20 |
| K073261 | VAR MONITOR | Vortran Medical Technology 1, Inc. | 2008-05-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10637320062004 | VORTRAN GO2VENT with PEEP Valve | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2021-05-04 |
| 10637320060017 | VORTRAN GO2VENT | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2019-05-03 |
| 10190752135673 | N/A | AirLife Finland Oy | 2019-04-15 |
| 10190752135680 | N/A | AirLife Finland Oy | 2019-04-15 |
| 10190752135697 | N/A | AirLife Finland Oy | 2019-04-15 |
| 10637320000105 | VORTRAN GO2VENT | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2017-06-07 |
| 10637320000167 | VORTRAN GO2VENT | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2017-06-07 |
| 10637320050117 | VAR (VORTRAN Automatic Resuscitator) with Manometer | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2016-06-14 |
| 08718969590044 | Ventrain | Ventinova Medical B.V. | 2016-02-09 |
| 10637320050100 | VAR (VORTRAN Automatic Resuscitator) | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2015-11-05 |
| 10637320050124 | VAR (VORTRAN Automatic Resuscitator) with Extension | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2015-11-04 |
| 10637320050025 | VAR (VORTRAN Automatic Resuscitator) with Extension | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2015-11-04 |
| 10637320050001 | VAR (VORTRAN Automatic Resuscitator) | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2015-11-04 |
| 10637320050018 | VAR (VORTRAN Automatic Resuscitator) with Manometer | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2015-11-04 |
| 09420012429933 | FISHER & PAYKEL HEALTHCARE | FISHER & PAYKEL HEALTHCARE LIMITED | 2015-09-25 |
| 09420012430014 | FISHER & PAYKEL HEALTHCARE | FISHER & PAYKEL HEALTHCARE LIMITED | 2015-09-25 |
| 09420012430007 | FISHER & PAYKEL HEALTHCARE | FISHER & PAYKEL HEALTHCARE LIMITED | 2015-09-25 |
| 09420012429995 | FISHER & PAYKEL HEALTHCARE | FISHER & PAYKEL HEALTHCARE LIMITED | 2015-09-25 |
| 09420012429988 | FISHER & PAYKEL HEALTHCARE | FISHER & PAYKEL HEALTHCARE LIMITED | 2015-09-25 |
| 09420012429971 | FISHER & PAYKEL HEALTHCARE | FISHER & PAYKEL HEALTHCARE LIMITED | 2015-09-25 |
| 10641043508008 | Neo-Tee T-Piece Resuscitator | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043508077 | Neo-Tee T-Piece Resuscitator | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043508084 | Neo-Tee T-Piece Resuscitator | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043508091 | Neo-Tee T-Piece Resuscitator | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043508107 | Neo-Tee T-Piece Resuscitator | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043508114 | Neo-Tee T-Piece Resuscitator | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043508138 | Neo-Tee T-Piece Resuscitator | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043508145 | Neo-Tee T-Piece Resuscitator | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043508152 | Neo-Tee T-Piece Resuscitator | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10610586045554 | Pneupac | ICU MEDICAL, INC. | 2015-09-01 |