Product Classification

• Device: sterilizer, ethylene-oxide gas
• Regulation Description: Ethylene oxide gas sterilizer.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: FLF
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Infection Control Devices (DHT4C)
• Submission Type: 510(k)
• Regulation Number: 880.6860
• 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

• 14-290 ANSI AAMI ST24:1999/(R)2018
  Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed.
• 14-588 AAMI TIR17:2017/(R)2020
  Compatibility of materials subjected to sterilization
• 14-606 ANSI AAMI ST24:2024
  General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
• 14-609 AAMI TIR17:2024
  Compatibility of materials subjected to sterilization

Third Party Review

Not Third Party Eligible