Product Classification

• Device: sterilizer, steam
• Regulation Description: Steam sterilizer.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: FLE
• Premarket Review: Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B); Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
• Submission Type: 510(k)
• Regulation Number: 880.6880
• 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

• 14-406 ANSI AAMI ST8:2013/(R)2018
  Hospital steam sterilizers
• 14-518 ANSI AAMI ST55:2016/(R)2023
  Table-top steam sterilizers
• 14-588 AAMI TIR17:2017/(R)2020
  Compatibility of materials subjected to sterilization
• 14-597 AAMI ANSI ST108:2023
  Water Quality for Processing Medical Devices
• 19-42 IEC 61326-1 Edition 3.0 2020-10
  Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc