Product Classification

• Device: sterilizer, dry heat
• Regulation Description: Dry-heat sterilizer.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: KMH
• 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: 880.6870
• 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

• 14-293 ANSI AAMI ST50:2004/(R)2018
  Dry heat (heated air) sterilizers
• 14-294 ANSI AAMI ST40:2004/(R)2018
  Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
• 14-588 AAMI TIR17:2017/(R)2020
  Compatibility of materials subjected to sterilization
• 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
• beanstock consulting
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc