Product Classification

• Device: thermometer, electronic, clinical
• Regulation Description: Clinical electronic thermometer.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: FLL
• Premarket Review: Drug Delivery and General Hospital Devices, and Human Factors (DHT3C); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(k)
• Regulation Number: 880.2910
• 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

• 6-124 ASTM E1104-98 (Reapproved 2016)
  Standard Specification for Clinical Thermometer Probe Covers and Sheaths
• 6-125 ASTM E1965-98 (Reapproved 2016)
  Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
• 6-177 ASTM E1112-00(2018)
  Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
• 6-405 IEC 80601-2-59 Edition 2.0 2017-09
  Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
• 6-421 ISO 80601-2-56 Second edition 2017-03
  Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].
• 13-52 ISO IEEE 11073-10408 First edition 2010-05-01
  Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
• 13-132 IEEE ISO 11073-10408 Second edition 2022-12
  Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer

Guidance Document

• Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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