Microlife Digital Infrared Forehead Thermometer Model FR1DM1

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K033820 ↗

FDA Product Code

FLL

Device Class

Class II

Regulation

21 CFR Part 880.2910

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• Is this thermometer reusable or designed for single-use, and how does that affect its clinical use?

  The Microlife Digital Infrared Forehead Thermometer (Model FR1DM1) is explicitly designed for single-use only. This is important because it is supplied sterile, ensuring hygiene for each measurement, which is critical in clinical settings where infection control is paramount. The single-use nature also eliminates the need for reprocessing, reducing potential contamination risks and simplifying workflow for intermittent temperature monitoring across all age groups.

• What temperature range does this device measure, and is it suitable for all patient populations?

  The device measures human body temperature within a range of 34.0°C to 42.2°C, which covers the typical physiological range for adults, children, and infants. Since it is classified as a forehead thermometer (Device Type: FLL) and intended for intermittent temperature monitoring, it is suitable for all age groups in both clinical and home settings. However, users should confirm its accuracy for their specific patient population, as extreme temperatures outside this range may not be reliably detected.

• How is this thermometer powered, and what are its physical dimensions for storage or inventory planning?

  The Microlife Digital Infrared Forehead Thermometer (Model FR1DM1) is powered by a single CR2032 battery, which is included in the packaging. Its compact dimensions are 122.36 mm (length) x 42.2 mm (width) x 43.11 mm (height), with a gross weight of 48 grams. These measurements make it easy to store in small clinical cabinets or carry in a pocket, while the lightweight design ensures minimal burden during use.

• What regulatory pathway was followed for FDA clearance, and how does that impact its use in hospitals?

  The device received FDA 510K clearance (K033820) under the Traditional Review pathway, classified as Substantially Equivalent (SESE) to a predicate device. It was reviewed by the General Hospital (HO) Advisory Committee and assigned the product code FLL (Forehead Thermometer). This clearance indicates it meets regulatory standards for general hospital applications, including intermittent temperature monitoring, and can be used in clinical settings where non-contact, rapid temperature assessment is required.