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Infrared Forehead Thermometer

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K202741

by Shenzhen Combei Technology Co., Ltd

Identifiers

510(k) Number
K202741 FDA 510(k)
FDA Product Code
FLL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.2910 FDA 510(k)
Regulation Number
880.2910 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Infrared Forehead Thermometer is a non-contact temperature measurement device classified under the nomenclature code FLL, designed for intermittent measurement and monitoring of body temperature via the forehead. It operates using infrared technology to detect thermal radiation emitted by the skin, providing rapid and accurate readings without physical contact.

This device is intended for use in general hospital settings and is supplied as a reusable medical instrument. It has received FDA 510(k) clearance under the Traditional pathway and complies with the Medical Device Directive (MDD). The thermometer is not single-use and requires proper storage and maintenance to ensure accuracy and hygiene.

Frequently asked questions

How is the Infrared Forehead Thermometer different from traditional contact thermometers, and what are its key benefits in a hospital setting?

Unlike traditional contact thermometers, this device uses non-contact infrared technology to measure forehead temperature without physical touch, reducing the risk of cross-contamination. Its rapid response time and ease of use make it ideal for busy hospital settings where quick, hygienic temperature checks are essential, particularly during patient triage or monitoring.

Is this thermometer meant for single-use, or can it be reused in a clinical environment? What maintenance is required?

This device is not single-use—it is designed as a reusable medical instrument for hospital settings. To maintain accuracy and hygiene, it requires proper cleaning, storage, and periodic maintenance as outlined in the manufacturer’s instructions, ensuring reliable performance over repeated use.

What regulatory pathways has this device followed, and how does that affect its use in hospitals?

The device has received FDA 510(k) clearance under the Traditional pathway and complies with the Medical Device Directive (MDD). This means it has undergone regulatory review to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets safety and performance standards for use in general hospital settings as specified.

Can this thermometer be used for continuous monitoring, or is it only for intermittent checks?

The device is explicitly designed for intermittent measurement and monitoring of body temperature, not continuous use. Its non-contact infrared technology is optimized for quick, periodic checks rather than prolonged tracking, making it suitable for routine patient assessments in hospitals.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K202741 FDA 510 (k) - Infrared Forehead Thermometer, Shenzhen Combei Technology Co.,Ltd., PDF July 7, 2021 Shenzhen Combei Technology Co., Ltd. Consultant Shenzhen ..., Shenzhen Combei Technology Co.,Ltd.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Combei Technology Co., Ltd
FDA Applicant
Shenzhen Combei Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K202741 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026