Product Classification

• Device: ventilator, emergency, powered (resuscitator)
• Regulation Description: Powered emergency ventilator.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: BTL
• Submission Type: 510(k)
• Regulation Number: 868.5925
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 5356-1 Third edition 2004-05-15 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
• 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
• CGA V-5:2008 Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications

Guidance Documents

• Draft Emergency Resuscitator Guidance  
• Draft Reviewer Guidance for Ventilators  

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.