Product Classification

• Device: high flow/high velocity humidified oxygen delivery device
• Regulation Description: High flow humidified oxygen delivery device.
• Definition: Intended to deliver high flow and/or high velocity oxygen with humidification.
• Physical State: This device can have a means of delivering humidified high flow and/or high velocity oxygen that may include high flow nasal cannula. The device may have a mechanical means of blending oxygen to the appropriate concentration.
• Technical Method: The device introduces humidified high flow and/or high velocity oxygen into the respiratory system.
• Target Area: Lung, airways, nasal passages
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: QAV
• 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: 868.5454
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 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
• 1-173 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
• 1-189 ISO 4135 Fourth edition 2022-01
  Anaesthetic and respiratory equipment - Vocabulary
• 1-196 ISO 80601-2-90 First edition 2021-08
  Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment

Third Party Review

Not Third Party Eligible