Product Classification

• Device: clinical electronic thermometer
• Regulation Description: Clinical electronic thermometer.
• Definition: A clinical electronic thermometer is a device used to intermittently measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. This product code is class II exempt, and was exempted, subject to the limitations of exemption, under the procedures established by section 510(m) of the FD&C Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 880.9 and the specific limitations of exemption as stated in the final order, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf
• Physical State: The device is portable and may be connected wired or wirelessly to another device. It uses a sensor to intermittently measure body temperature either by direct contact or via a non-contact infrared sensor.
• Technical Method: A clinical electronic thermometer is a device used to intermittently measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The device does not have telethermographic or continuous temperature measurement functions.
• Target Area: Common measurement sites include the sublingual space in the mouth, rectum, ear canal, armpit, or the forehead
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: SDV
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(K) Exempt
• Regulation Number: 880.2910
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible

Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.

• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 6-124 ASTM E1104-98 (Reapproved 2023)
  Standard Specification for Clinical Thermometer Probe Covers and Sheaths
• 6-125 ASTM E1965-98 (Reapproved 2023)
  Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
• 6-177 ASTM E1112-00 (Reapproved 2018)
  Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
• 6-421 ISO 80601-2-56 Second edition 2017-03 [Including AMD1:2018]
  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

Third Party Review

Not Third Party Eligible