Product Classification

• Device: filter, bacterial, breathing-circuit
• Regulation Description: Breathing circuit bacterial filter.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: General Hospital
• Product Code: CAH
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
• Submission Type: 510(k)
• Regulation Number: 868.5260
• 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
• 1-134 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

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc