Product Classification

• Device: ventilator, non-continuous (respirator)
• Regulation Description: Noncontinuous ventilator (IPPB).
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: BZD
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
• Submission Type: 510(k)
• Regulation Number: 868.5905
• 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?: No

Recognized Consensus Standards

• 1-62 ISO 5356-1 Third edition 2004-05-15
  Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
• 1-106 ISO 17510 First Edition 2015-08-01
  Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories
• 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
• 1-136 ISO 18562-3 First edition 2017-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
• 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
• 1-138 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
• 1-151 ISO 80601-2-70 Second edition 2020-11
  Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
• 1-173 ISO 18562-1 Second edition 2024-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
• 1-174 ISO 18562-2 Second edition 2024-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
• 1-175 ISO 18562-3 Second Edition 2024-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
• 1-176 ISO 18562-4 Second Edition 2024-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
• 1-177 ISO 80601-2-74 Second edition 2021-07
  Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
• 13-74 IEEE Std 11073-10424-2014
  Health informatics - Personal health device communication, Part 10424: Device Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE)
• 13-94 ISO IEEE 11073-10424 First edition 2016-06-15
  Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)]

Guidance Document

• Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II

Third Party Review

Not Third Party Eligible