BTM · Ventilator, Emergency, Manual (Resuscitator)
Anesthesiology · 21 CFR 868.5915 · Class 2
Overview
| Product Code | BTM |
|---|---|
| Device Name | Ventilator, Emergency, Manual (Resuscitator) |
| Regulation | 21 CFR 868.5915 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 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 | The BAG manual resuscitator and accessories | Laerdal Medical AS | Nov 24, 2025 | SESE |
| K243861 | butterflyBVM | Compact Medical, Inc. | Apr 25, 2025 | SESE |
| K221841 | EOlife® | Archeon | Mar 18, 2023 | SESE |
| K212905 | Sotair Device | Safe Bvm Corporation | Aug 18, 2022 | SESE |
| K210288 | Disposable Manual Resuscitator | Xiamen Compower Medical Tech. Co., Ltd. | Aug 26, 2021 | SESE |
| K181583 | 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 | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer | Foremount Enterprise Co., Ltd. | May 11, 2018 | SESE |
| K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator | Ambu A/S | Aug 29, 2016 | SESE |
| K132172 | NEONATALIE RESUSCITATOR | Laerdal Medical A/S | Jan 15, 2015 | SESE |
| K112852 | BABI PLUS NEONATAL RESUSCITATION BAG | A Plus Medical | Jan 13, 2012 | SESE |
| K102824 | AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC | Ambu A/S | Jan 28, 2011 | SESE |
| K102649 | NEOPOP INFANT RESUSCITATOR WITH FLOW METER | Neoforce Group, Inc. | Jan 6, 2011 | SESE |
| K094003 | REVIVATOR | Hersill, S.L. | Sep 17, 2010 | SESE |
| K093081 | POCKET BVM | Microbvm Systems , Ltd. | Feb 5, 2010 | SESE |
| K082092 | DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE | Galemed Corp. | Oct 15, 2008 | SESE |
| K073410 | SAVE RESUSCITATOR | Artivent Corporation | Sep 12, 2008 | SESE |
| K073171 | RESUSCITATION TIMER, MODEL L770-CPR | Allied Healthcare Products, Inc. | Jan 31, 2008 | SESE |
| K072021 | NEOPIP INFANT RESUSCITATOR | Neoforce Group, Inc. | Sep 12, 2007 | SESE |
| K070247 | GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM | Ohmeda Medical | Apr 20, 2007 | SESE |
| K062080 | 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
