Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5925](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5925) → BTL — Ventilator, Emergency, Powered (Resuscitator) # BTL · Ventilator, Emergency, Powered (Resuscitator) _Anesthesiology · 21 CFR 868.5925 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL ## Overview - **Product Code:** BTL - **Device Name:** Ventilator, Emergency, Powered (Resuscitator) - **Regulation:** [21 CFR 868.5925](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5925) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K242769.md) | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) | Draegerwerk AG & CO Kgaa | Apr 4, 2025 | SESE | | [K221634](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K221634.md) | Oxymag - Transport and Emergency Ventilator | Magnamed Tecnologia Medica S/A | May 24, 2023 | SESE | | [K202219](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K202219.md) | VORTRAN GO2VENT with PEEP Valve | Vortran Medical Technology 1, Inc. | Feb 11, 2021 | SESE | | [K193191](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K193191.md) | MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag | Weinmann Emergency Medical Technology GmbH + Co. KG | Nov 20, 2020 | SESE | | [K182956](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K182956.md) | Puffin Lite Infant Resuscitation System | International Biomedical | Jan 18, 2019 | SESE | | [K173373](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K173373.md) | SafeT T-Piece Resuscitator | Ventlab, LLC | Nov 16, 2018 | SESE | | [K161420](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K161420.md) | MOVES SLC | Thornhill Research, Inc. | Jun 6, 2017 | SESE | | [K162968](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K162968.md) | VORTRAN GO2VENT | Vortran Medical Technology 1, Inc. | Apr 10, 2017 | SESE | | [K141595](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K141595.md) | O-TWO E700,O-TWO E600,O-TWO E500 | O-Two Medical Technologies, Inc. | Mar 16, 2015 | SESE | | [K142096](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K142096.md) | T-PIECE RESUSCITATOR | Mercury Medical | Oct 17, 2014 | SESE | | [K140049](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K140049.md) | MOVES SLC | Thornhill Research, Inc. | May 29, 2014 | SESE | | [K140707](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K140707.md) | LIFEBORNE INFANT RESUSCITATOR | International Biomedical | May 28, 2014 | SESE | | [K131098](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K131098.md) | EMERGENCY PORTABLE VENTILATOR | Allied Healthcare Products, Inc. | Apr 9, 2014 | SESE | | [K132021](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K132021.md) | AHP 300, EMERGENCY PORTABLE VENTILATOR | Allied Healthcare Products, Inc. | Apr 2, 2014 | SESE | | [K132759](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K132759.md) | VENTRAIN | Dolphys Medical B.V. | Mar 26, 2014 | SESE | | [K131877](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K131877.md) | SAVE II, SAVE II BASIC | Automedx, Inc. | Mar 21, 2014 | SESE | | [K123957](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K123957.md) | PNEUPAC PARAPAC PLUS | Smiths Medical International , Ltd. | Sep 16, 2013 | SESE | | [K112783](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K112783.md) | MANUJET III | VBM Medizintechnik GmbH | Dec 22, 2011 | SESE | | [K102542](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K102542.md) | RESUSCI FLOW; RESUSCI FLOW 104 | Atom Medical Corporation | Apr 6, 2011 | SESE | | [K093862](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K093862.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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