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Infrared Forehead Thermometer IR-FT

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191668

by Comper Chuangxiang (Beijing) Technology Co., Ltd.

Identifiers

510(k) Number
K191668 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 IR-FT is a non-contact temperature measurement device designed to rapidly assess core body temperature via infrared thermal imaging of the forehead. Classified as a forehead thermometer under product code FLL, it adheres to ASTM E 1965 standards for accuracy and performance in clinical settings. This device eliminates physical contact, reducing cross-contamination risks while providing quick readings for patient monitoring.

The IR-FT is supplied as a single-use or reusable device (as per manufacturer specifications) and is intended for use in general hospital environments. It operates without MRI interference, ensuring compatibility with magnetic resonance imaging areas. Storage requirements and sterility protocols are detailed in the accompanying user manual, which also outlines regulatory compliance under FDA 510(k) clearance (K191668) as a substantially equivalent device. No additional regulatory markings or certifications are stated beyond the provided authorization.

Frequently asked questions

How does the Infrared Forehead Thermometer IR-FT measure temperature without physical contact?

The IR-FT uses infrared thermal imaging to detect the heat emitted from the forehead, converting it into a digital temperature reading. This method avoids direct skin contact, minimizing cross-contamination risks while providing a quick assessment of core body temperature in clinical settings.

Is the Infrared Forehead Thermometer IR-FT single-use or reusable, and how should it be stored?

The IR-FT can be supplied as either single-use or reusable, depending on the manufacturer’s specifications. Storage instructions are detailed in the user manual, which also outlines sterility protocols. Proper storage ensures accuracy and compliance with clinical hygiene standards.

Can the Infrared Forehead Thermometer IR-FT be used in MRI-compatible areas?

Yes, the IR-FT is designed to operate without MRI interference, making it suitable for use in magnetic resonance imaging areas. This ensures compatibility in environments where traditional thermometers may pose risks.

What regulatory approval does the Infrared Forehead Thermometer IR-FT hold?

The IR-FT holds FDA 510(k) clearance (K191668) as a substantially equivalent device under product code FLL, intended for general hospital use. The accompanying user manual includes additional regulatory compliance details.

What standards does the Infrared Forehead Thermometer IR-FT meet for accuracy?

The IR-FT adheres to ASTM E 1965 standards for accuracy and performance in clinical settings. This ensures reliable temperature readings for patient monitoring, particularly in environments where precision and hygiene are critical.

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: COMPER IR-FT USER MANUAL Pdf Download | ManualsLib, COMPER IR-FT USER MANUAL Pdf Download | ManualsLib, Comper IR-FT Infrared Forehead Thermometer User Manual, Comper Chuangxiang IRFT Infrared Forehead Thermometer User Manual

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Comper Chuangxiang (Beijing) Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K191668 24 fields · synced Oct 1, 2026