BTL — Ventilator, Emergency, Powered (Resuscitator) Class II
FDA product code BTL covers "Ventilator, Emergency, Powered (Resuscitator)", a Class II medical device regulated under 21 CFR 868.5925. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BTL
- Device Class
- Class II
- Regulation Number
- 868.5925
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242769 | draegerwerk ag and co kgaa | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) | April 4, 2025 |
| K221634 | magnamed tecnologia medica s/a | Oxymag - Transport and Emergency Ventilator | May 24, 2023 |
| K202219 | vortran medical technology 1 | VORTRAN GO2VENT with PEEP Valve | February 11, 2021 |
| K193191 | weinmann emergency medical technology gmbh + co. kg | MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag | November 20, 2020 |
| K182956 | international biomedical | Puffin Lite Infant Resuscitation System | January 18, 2019 |
| K173373 | ventlab | SafeT T-Piece Resuscitator | November 16, 2018 |
| K161420 | thornhill research | MOVES SLC | June 6, 2017 |
| K162968 | vortran medical technology 1 | VORTRAN GO2VENT | April 10, 2017 |
| K141595 | o-two medical technologies | O-TWO E700,O-TWO E600,O-TWO E500 | March 16, 2015 |
| K142096 | mercury medical | T-PIECE RESUSCITATOR | October 17, 2014 |
| K140049 | thornhill research | MOVES SLC | May 29, 2014 |
| K140707 | international biomedical | LIFEBORNE INFANT RESUSCITATOR | May 28, 2014 |
| K131098 | allied healthcare products | EMERGENCY PORTABLE VENTILATOR | April 9, 2014 |
| K132021 | allied healthcare products | AHP 300, EMERGENCY PORTABLE VENTILATOR | April 2, 2014 |
| K132759 | dolphys medical | VENTRAIN | March 26, 2014 |
| K131877 | automedx | SAVE II, SAVE II BASIC | March 21, 2014 |
| K123957 | smiths medical international | PNEUPAC PARAPAC PLUS | September 16, 2013 |
| K112783 | vbm medizintechnik | MANUJET III | December 22, 2011 |
| K102542 | atom medical corporation | RESUSCI FLOW; RESUSCI FLOW 104 | April 6, 2011 |
| K093862 | o-two medical technologies | CAREVENT HANDHELD CPAP SYSTEM | May 6, 2010 |