Product Classification

• Device: ventilator, emergency, powered (resuscitator)
• Regulation Description: Powered emergency ventilator.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: BTL
• Premarket Review: Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C); Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
• Submission Type: 510(k)
• Regulation Number: 868.5925
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: Yes

Recognized Consensus Standards

• 1-62 ISO 5356-1 Third edition 2004-05-15
  Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
• 1-72 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
• 1-81 CGA V-5:2008 (Reaffirmed 2013)
  Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)
• 1-134 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
• 1-135 ISO 18562-2 First edition 2017-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
• 1-137 ISO 18562-4 First edition 2017-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
• 1-160 ISO 80601-2-84 First edition 2020-07
  Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment

Third Party Review

Not Third Party Eligible