Infrared Ear Thermometer, Models TH88 Series

510(k) Number

K020504 ↗

FDA Product Code

FLL

FDA applicant

Radiant Innovation, Inc.

Device Class

Class II

Regulation

21 CFR Part 880.2910

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Multi-function Infrared Thermometer

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  CE/MDD

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• RII Infrared Ear Thermometer, Model TH60N

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See all devices from Radiant Innovation Inc. →

• What types of settings is this infrared ear thermometer approved for use in, and how does that affect its suitability for different environments?

  The device is authorized under FDA 510(k) clearance (K020504) and classified under product code FLL, which specifies it for hospital use. This means it is designed for clinical environments like hospitals, where precise and rapid temperature measurements are critical. While it may technically function in other settings, its regulatory classification and intended use align with hospital or medical facility protocols. Always verify local guidelines to ensure compliance with your specific environment’s requirements.

• How is the device supplied, and what precautions should be taken to maintain its integrity before use?

  The Infrared Ear Thermometer (TH88 Series) is supplied as a reusable medical instrument, but it includes single-use disposable probe covers to prevent cross-contamination. These covers must be used per each measurement to ensure sterility and hygiene. Store the device in a clean, dry environment following standard medical device protocols—either sterile or non-sterile, depending on the manufacturer’s instructions—to preserve its functionality and prevent damage.

• Is this thermometer designed for repeated use, and if so, how should it be cleaned and maintained between patients?

  Yes, the device is reusable, but it relies on single-use disposable probe covers for each measurement to maintain hygiene. Between uses, follow the manufacturer’s guidelines for cleaning and maintenance, which typically include disinfection (if applicable) and proper storage to prevent contamination. The reusable nature means it must be handled according to infection control protocols to ensure accuracy and safety across multiple patients.

• What distinguishes this infrared ear thermometer from traditional contact-based thermometers, and how does that impact its use?

  This device is non-contact, using infrared technology to detect thermal radiation from the eardrum via the auditory canal without physical contact. This eliminates the need for probe insertion, reducing patient discomfort and cross-contamination risks. The rapid measurement capability (enabled by the thermopile detector) makes it ideal for quick assessments, such as in pediatric or high-volume clinical settings where speed and precision are critical.