Infrared Ear and Forehead Thermometer YI-100
by Wenzhou Yosun Medical Technology Co., Ltd. EUDAMED510(k)
Active
510(k) K201843
Overview
The Infrared Ear and Forehead Thermometer YI-100 is a non-contact temperature measurement device designed for rapid and accurate body temperature assessment. It utilises infrared technology to measure thermal radiation emitted from the ear canal or forehead, providing a quick reading without physical contact.
This device is intended for single-use or reusable clinical settings, including general hospitals, and is supplied sterile or non-sterile as specified by the manufacturer. It complies with FDA 510(k) clearance under the Traditional pathway, with a decision classification of Substantially Equivalent (SESE) and product code FLL. Storage and handling follow standard medical device protocols to ensure accuracy and reliability.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK201843 | Date23 Oct 2020 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Full name
- Infrared ear and forehead thermometer, model YI-100
- 510(k) Number
- FDA Product Code
- FLL
- FDA applicant
- Wenzhou Yosun Medical Technology Co.,Ltd
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
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Questions
What types of clinical settings is this thermometer approved for use in?
The YI-100 is approved for use in general hospitals, as indicated by its advisory committee classification (HO). This makes it suitable for routine temperature checks in inpatient, outpatient, or emergency care environments where rapid, non-contact measurements are needed.
Can this device be reused, or is it intended for single-use only?
The manufacturer specifies the YI-100 can be used in either single-use or reusable clinical settings, depending on the sterile or non-sterile configuration selected. Reuse requires adherence to standard medical device reprocessing protocols to maintain accuracy and safety.
How does the infrared technology in this thermometer work, and why is it preferred in certain situations?
The YI-100 measures body temperature by detecting infrared thermal radiation emitted from the ear canal or forehead, eliminating the need for physical contact. This makes it ideal for quick assessments in high-throughput settings (like triage) or when minimizing exposure risk (e.g., during infectious disease screening).
What regulatory pathways does this device follow, and how does that affect its use?
The YI-100 is cleared under the FDA’s 510(k) Traditional pathway as *Substantially Equivalent* (SESE) to a predicate device, with product code FLL. This classification confirms it meets U.S. safety and performance standards for non-invasive temperature measurement. Outside the U.S., it complies with the EU’s Medical Device Regulation (MDR) and the Medical Device Directive (MDD).
How should storage conditions be managed to ensure the device remains accurate?
While specific storage details aren’t listed, standard protocols for infrared thermometers—such as avoiding extreme temperatures, humidity, or direct sunlight—should be followed. The manufacturer’s instructions (not provided here) likely outline ideal conditions to preserve calibration and reliability over time.