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The Infrared Forehead Thermometer, Model Fs-300&301

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K101912

by HuBDIC Co., Ltd.

Identifiers

510(k) Number
K101912 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 FS-300 & FS-301 is a non-contact temperature measurement device designed to rapidly assess core body temperature via infrared thermal scanning of the forehead. It falls under the category of infrared thermometers, providing a quick and contactless alternative to traditional mercury or digital oral/rectal thermometers for clinical and general hospital use.

This device is intended for single-use or reusable applications in general hospital settings, depending on manufacturer guidelines. Supplied sterile or non-sterile as specified, it adheres to FDA 510(k) clearance (K101912) and EU MDR compliance, ensuring regulatory alignment for medical use. The FS-300 & FS-301 models are designed for ease of use, with no specific MRI safety restrictions noted, and require proper storage as per manufacturer instructions to maintain accuracy and functionality.

Frequently asked questions

How do the FS-300 and FS-301 models differ in terms of use and regulatory compliance?

Both the FS-300 and FS-301 are infrared forehead thermometers designed for non-contact temperature measurement, but they share identical regulatory compliance—both are FDA 510(k)-cleared (K101912) and EU MDR-compliant. The key distinction lies in their intended use flexibility: they can be used for single-use or reusable applications in general hospital settings, depending on manufacturer guidelines for cleaning and sterilization. No model-specific differences in functionality or approvals are noted in the provided data.

Can this thermometer be used in an MRI environment, and if not, why?

The Infrared Forehead Thermometer FS-300 & FS-301 does not have any specific MRI safety restrictions mentioned in the provided data. This implies it is not explicitly contraindicated for use in MRI environments, though users should still follow standard electromagnetic interference guidelines and manufacturer instructions to ensure safe operation near MRI machines. Always verify compatibility with your facility’s MRI protocols.

What are the storage requirements for maintaining accuracy and functionality of this device?

The device requires proper storage as per the manufacturer’s instructions to preserve its accuracy and functionality. While specific storage conditions (e.g., temperature, humidity) aren’t detailed here, typical infrared thermometers should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposure to moisture or contaminants that could compromise the sensor or lens.

Is this thermometer suitable for both clinical and general hospital use, and how does that affect its design?

Yes, the FS-300 & FS-301 are explicitly designed for general hospital settings, including clinical use. Their non-contact infrared design allows for rapid, hygienic temperature assessment without physical contact, which is particularly advantageous in clinical environments where infection control is critical. The flexibility for single-use or reusable applications further supports their versatility in diverse hospital settings.

How do I determine whether the device I receive is sterile or non-sterile?

The sterility of the Infrared Forehead Thermometer FS-300 & FS-301 depends on the specific order or packaging instructions from the manufacturer. The device is described as being supplied *sterile or non-sterile as specified*, meaning the supplier or manufacturer will indicate sterility status (e.g., through packaging labels or documentation). Always verify this information with the distributor or refer to the accompanying instructions before use.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
HuBDIC Co., Ltd.

Sources (2)

  • FDA 510(k) K101912 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026