FDA-Authorized Ventilators for COVID-19

Pursuant to section 564(d)(1) of the Federal Food, Drug, and Cosmetic Act, the Secretary of the Department of Health and Human Services has thus far authorized the following “ventilators” for use in healthcare settings during the COVID-19 pandemic.

  • AirCurve ST by RESMED
  • AirCurve 10 ST-A by RESMED
  • Apogee by Incoba LLC
  • Atlan A350 and Atlan A350 XL by Drägerwerk AG & Co. KGaA
  • Babylog VN800 and VN600 by Drägerwerk AG & Co. KGaA
  • Conventor Adult Manual Resuscitator Compressor by University of Minnesota Medical School and Boston Scientific Corporation
  • COVID Ventor by CoLabs
  • CP101/CP101S Series by SLS Medical Technology Corp. Ltd.
  • DM28- 20A-W and DM28- 20A-WP by Shenzhen Yamind Medical Tech
  • DM28-20C-G by Shenzhen Yamind Medical Tech
  • DM28-20S-G, DM28-20SA-G, DM28-20ST-G, DM28-25S-B, DM28-25SA-BP, DM28-25ST-BP, DM28-30ST-B, DM28-30ST-BP, and DM28-30STA-BP by Shenzhen Yamind Medical Tech
  • E30 ventilator by Philips Respironics
  • Evita V800 and Evita V600 by Drägerwerk AG & Co. KGaA
  • Flexo Bi-Level ST by RESMED
  • GA ST by RESMED
  • iBreeze 30STA device by Resvent Medical Technology Co. Ltd.
  • JIXI H-100 by Jiuxin Medical
  • LA Series Ventilators LA20C, LA20A, LA20B, LA25B by Zhejiang LifeMed Technology Co. Ltd.
  • LTV2 model 2200 and LTV model 2150 by Vyaire Medical Inc.
  • Lumis 150 VPAP ST by RESMED
  • Luna G3 B30VT by 3B Medical Inc.
  • Luna G3 BPAP 25A-LG3700 by BMC Medical Co. Ltd.
  • Luna G3 BPAP S/T-LG3800-G3 B30VT by BMC Medical Co. Ltd.
  • Mechanical Ventilator Milano by Elemaster S.p.A. Tecnologie Elettroniche
  • MetaNeb 4 by Hillrom
  • Mindray SV300/SV60/SV800 ventilators by Shenzen Mindray Biomedical Electronics
  • Models 6000S, T5, T7 by AMBULANC TECH Co. Ltd.
  • MTV1000 ventilator by MEKICS Co. Ltd.
  • Pneumatic Resuscitator device by SecondBreath LLC
  • pNeuton Model A-E Ventilator by GE Healthcare
  • PREVENT by PVA
  • Puritan Bennett 560 Ventilator System by Covidien LLC
  • SaVe II Series Ventilator by AutoMedX Inc.
  • Spiro Wave by Spiro Devices LLC
  • Stellar 150 by RESMED
  • UMC-001 EUA by Umbulizer
  • V+Pro Emergency Ventilator by VenTec Life Systems
  • Vayu bubble Continuous Positive Airway Pressure Circuit by Vayu Global Health Innovations
  • Venti-Now Resuscitator Model JM-P2020A by Venti-Now
  • Ventway Sparrow by Innovytec
  • VG70 ventilator by Beijing Aeonmed Co. Ltd.
  • Virgin Orbit Resuscitator by Virgin Orbit
  • VITAL ventilator by NASA Jet Propulsion Laboratory
  • VX850 Ventilator by Philips Respironics
  • Y-30T by BMC Medical Co. Ltd.
  • YUWELL® YH-730 Bi-level PAP and YH-830 Bi-level PAP by Amsino
  • YUWELL® YH-725 BiPAP by Amsino International Inc.
  • Wilcox PATRIOT SAVR by Wilcox Industries Corp.
  • ZXH-550 by Zibo Zhongxun Medical Equipment Co. Ltd.

The following tubing connectors and accessories have also been approved.

  • 3B Hi-Flow H80 by 3B Medical, Inc.
  • DAR Adult Dual Patient Breathing Circuit 301P14429 by Covidien LLC
  • Formlabs 3D Printer BiPAP Adapter by Formlabs Inc.
  • Janisys CPAP Flow Generator by Janisys
  • Northwell 3D Printed BiPAP Adapter by Northwell Health, Inc.
  • ReddyPort Mini NIV Access Elbow by SMD Manufacturing, LLC
  • Vent Multiplexor by Vent Multiplexor LLC
  • Ventilation Expansion Splitter (VESper) by Prisma Health
  • VentMI by MakeMedical

Classification Regulations: Device Type(s) (Product Code)

Ventilators

  • 21 CFR 868 5160: Gas machine, anesthesia (BSZ)
  • 21 CFR 868.5454: High flow/high velocity humidified oxygen delivery device (QAV)
  • 21 CFR 868.5895: Ventilator, Continuous, Facility Use (CBK); Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (MNT); Continuous, ventilator, home use (NOU); Ventilator, continuous, minimal ventilatory support, home use (NQY); Ventilator, continuous, non-life-supporting (MNS); Mechanical Ventilator (ONZ)
  • 21 CFR 868.5905: Ventilator, non-continuous (respirator) including masks and interfaces under the same product code (BZD); Conserver, Oxygen (NFB); Device, Positive Pressure Breathing Intermitten (NHJ); Resuscitator, Manual Non Self-Inflating (NHK)
  • 21 CFR 868.5925: Ventilator, Emergency, Powered (Resuscitator) (BTL)

Tubing connectors and accessories

  • 21 CFR 868.5240: Anesthesia breathing circuit (OFP); Anesthesia breathing circuit (CAI)
  • 21 CFR 868.5260: Filter, Bacterial, Breathing-Circuit (CAH)
  • 21 CFR 868.5270: Heated breathing circuit (BZE)
  • 21 CFR 868.5340: Cannula, Nasal, Oxygen (CAT)
  • 21 CFR 868.5440: Generator, oxygen, portable (CAW)
  • 21 CFR 868.5450: Humidifier, Respiratory Gas, (Direct Patient Interface) (BTT)
  • 21 CFR 868.5580: Mask, Oxygen (BYG)
  • 21 CFR 868.5730: Tube, Tracheal (W/Wo Connector) (BTR); Airway Monitoring System (OQU)
  • 21 CFR 868.5895: Accessory to Continuous Ventilator (Respirator) (MOD)
  • 21 CFR 868.5965: Attachment, Breathing, Positive End Expiratory Pressure (BYE)
  • 21 CFR 868.5975: Set, Tubing and Support, Ventilator (BZO)

Declarations of Conformity

  • IEC 60601-1: 2012: Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
  • IEC 60601-1-2: 2014: Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests
  • IEC 60601-1-11: 2015: Medical Electrical Equipment Part 1-11: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
  • Any other applicable collateral/particular standards in the IEC 60601-1: 2012 family
  • IEC 62304: 2015: Medical Device Software – Software Life Cycle Processes
  • AAMI TIR69: 2017: Technical Information Report Risk Management of Radio-
    Frequency Wireless Coexistence for Medical Devices and Systems
  • ANSI/IEEE C63.27: 2017: American National Standard for Evaluation of Wireless
    Coexistence
  • AAMI TIR69: 2017: Technical Information Report Risk Management of Radio-
    Frequency Wireless Coexistence for Medical Devices and Systems
  • ISO 10993: Fifth Edition 2018-08: Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
  • ISO 18562-1 First Edition 2017-03: Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications – Part 1: Evaluation and Testing Within a Risk Management Process
  • ISO 18562-2 First Edition 2017-03: Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications – Part 2: Tests for Emissions of Particulate Matter
  • ISO 18562-3 First Edition 2017: Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications – Part 3: Tests for Emissions of Volatile Organic Compounds
  • ISO 18562-4 First Edition 2017-03: Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications – Part 4: Tests for Leachables in Condensate
  • ISO 10651-5 First Edition 2006-02-01: Lung Ventilators for Medical Use – Particular Requirements for Basic Safety and Essential Performance – Part 5: Gas-Powered Emergency Resuscitators
  • ISO 17510 First Edition 2015-08-01: Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
  • ISO 80601-2-12 First Edition 2011-04-15: Medical Electrical Equipment – Part 2-12: Particular Requirements for the Safety of Lung Ventilators – Critical Care Ventilators [Including: Technical Corrigendum 1 (2011)]
  • ISO 80601-2-13 First Edition 2011-08-11: Medical Electrical Equipment — Part 2-13: Particular Requirements for Basic Safety and Essential Performance of an Anaesthetic Workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)]
  • ISO 80601-2-69 First Edition 2014-07-15: Medical Electrical Equipment – Part 2-69: Particular Requirements for Basic Safety and Essential Performance of Oxygen Concentrator Equipment
  • ISO 80601-2-70 First Edition 2015-01-15: Medical Electrical Equipment – Part 2-70: Particular Requirements for Basic Safety and Essential Performance of Sleep Apnoea Breathing Therapy Equipment
  • ISO 80601-2-74 First Edition 2017-05: Medical Electrical Equipment – Part 2-74: Particular Requirements for Basic Safety and Essential Performance of Respiratory Humidifying Equipment
  • ISO 80601-2-79 First Edition 2018-07: Medical electrical equipment – Part 2-79: Particular Requirements for Basic Safety and Essential Performance of Ventilatory Support Equipment for Ventilatory Impairment
  • ISO 80601-2-80 First Edition 2018-07: Medical Electrical Equipment – Part 2-80: Particular Requirements for Basic Safety and Essential Performance of Ventilatory Support Equipment for Ventilatory Insufficiency