Non-Contact Infrared Thermometer
by K-jump Health Co., Ltd. 510(k)
Active
510(k) K102947
Overview
The Non-Contact Infrared Thermometer KI-8280 is an electronic clinical thermometer classified under Thermometer, Electronic, Clinical (21 CFR 880.2910). It operates by detecting infrared radiation emitted from the human body to measure temperature without physical contact, ensuring rapid and non-invasive readings.
This device is supplied as a single-use or reusable instrument (as per manufacturer specifications) and is intended for use in general hospital settings. It complies with FDA 510(k) clearance (K102947) under the Traditional review pathway, with no third-party involvement. Storage and handling instructions are detailed in the accompanying manual, though regulatory status beyond the stated clearance is not specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK102947 | Date25 Feb 2011 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FLL
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
Our product lines include devices in thermometry, cardiovascular care, respiratory care and diabetes care.
Other devices from K-jump Health Co., Ltd.
Questions
How does the Non-Contact Infrared Thermometer KI-8280 differ from traditional contact thermometers in terms of use and convenience?
The KI-8280 measures body temperature by detecting infrared radiation emitted from the human body, eliminating the need for physical contact. This design allows for rapid, non-invasive readings—ideal for clinical settings where speed and hygiene are critical, such as general hospitals. Unlike contact thermometers, it avoids potential cross-contamination risks and reduces patient discomfort, particularly for those who may be sensitive to touch or have skin conditions.
Is the Non-Contact Infrared Thermometer KI-8280 designed for single-use or reusable applications, and how does this affect its clinical utility?
The KI-8280 is supplied as either a single-use or reusable instrument, depending on the manufacturer’s specifications. This flexibility allows clinicians to choose based on their facility’s infection control protocols and budget constraints. Reusable models may be cost-effective for high-volume settings, while single-use versions offer convenience and reduce cleaning requirements, minimizing downtime between patients.
What regulatory pathway was followed for the FDA clearance of the Non-Contact Infrared Thermometer KI-8280, and what does this mean for its clinical adoption?
The KI-8280 received FDA clearance under the Traditional 510(k) review pathway (K102947) with a Substantially Equivalent (SESE) determination, meaning it was compared to a legally marketed predicate device. This pathway ensures the device meets established safety and performance standards for electronic clinical thermometers. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though they should always follow the manufacturer’s instructions for proper use and maintenance.
Are there specific storage or handling requirements for the Non-Contact Infrared Thermometer KI-8280 that clinicians should be aware of?
While the exact storage and handling instructions are detailed in the accompanying manual provided by K-Jump Health Co., Ltd., proper care is essential to maintain accuracy and longevity. Typically, such devices should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Clinicians should follow the manufacturer’s guidelines to ensure calibration stability and prevent damage to the infrared sensor, which is critical for reliable temperature readings.