Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5915](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5915) → BTM — Ventilator, Emergency, Manual (Resuscitator) # BTM · Ventilator, Emergency, Manual (Resuscitator) _Anesthesiology · 21 CFR 868.5915 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM ## Overview - **Product Code:** BTM - **Device Name:** Ventilator, Emergency, Manual (Resuscitator) - **Regulation:** [21 CFR 868.5915](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5915) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **3rd-party reviewable:** yes - **Life-sustaining:** yes ## Identification A manual emergency ventilator is a device, usually incorporating a bag and valve, 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 209) Showing 20 most recent of 209 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251631](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K251631.md) | The BAG manual resuscitator and accessories | Laerdal Medical AS | Nov 24, 2025 | SESE | | [K243861](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K243861.md) | butterflyBVM | Compact Medical, Inc. | Apr 25, 2025 | SESE | | [K221841](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K221841.md) | EOlife® | Archeon | Mar 18, 2023 | SESE | | [K212905](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K212905.md) | Sotair Device | Safe Bvm Corporation | Aug 18, 2022 | SESE | | [K210288](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K210288.md) | Disposable Manual Resuscitator | Xiamen Compower Medical Tech. Co., Ltd. | Aug 26, 2021 | SESE | | [K181583](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K181583.md) | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20 | Flexicare Medical Limited. | Dec 7, 2018 | SESE | | [K170663](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K170663.md) | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer | Foremount Enterprise Co., Ltd. | May 11, 2018 | SESE | | [K152931](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K152931.md) | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator | Ambu A/S | Aug 29, 2016 | SESE | | [K132172](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K132172.md) | NEONATALIE RESUSCITATOR | Laerdal Medical A/S | Jan 15, 2015 | SESE | | [K112852](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K112852.md) | BABI PLUS NEONATAL RESUSCITATION BAG | A Plus Medical | Jan 13, 2012 | SESE | | [K102824](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K102824.md) | AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC | Ambu A/S | Jan 28, 2011 | SESE | | [K102649](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K102649.md) | NEOPOP INFANT RESUSCITATOR WITH FLOW METER | Neoforce Group, Inc. | Jan 6, 2011 | SESE | | [K094003](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K094003.md) | REVIVATOR | Hersill, S.L. | Sep 17, 2010 | SESE | | [K093081](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K093081.md) | POCKET BVM | Microbvm Systems , Ltd. | Feb 5, 2010 | SESE | | [K082092](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K082092.md) | DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE | Galemed Corp. | Oct 15, 2008 | SESE | | [K073410](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K073410.md) | SAVE RESUSCITATOR | Artivent Corporation | Sep 12, 2008 | SESE | | [K073171](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K073171.md) | RESUSCITATION TIMER, MODEL L770-CPR | Allied Healthcare Products, Inc. | Jan 31, 2008 | SESE | | [K072021](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K072021.md) | NEOPIP INFANT RESUSCITATOR | Neoforce Group, Inc. | Sep 12, 2007 | SESE | | [K070247](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K070247.md) | GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM | Ohmeda Medical | Apr 20, 2007 | SESE | | [K062080](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K062080.md) | RESUSCITATION TIMER, MODEL L770-CPR | Allied Healthcare Products, Inc. | Oct 18, 2006 | SESE | ## Top Applicants - Ambu, Inc. — 15 clearances - Puritan Bennett Corp. — 12 clearances - Medical Marketing Concepts — 11 clearances - Life Design Systems, Inc. — 7 clearances - Engineered Medical Systems — 6 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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