Infrared Ear Thermometer Model KI-8120
by K-jump Health Co., Ltd. 510(k)
Active
510(k) K984551
Overview
The Infrared Ear Thermometer Model Ki-8120 is a non-contact medical device designed to measure body temperature by detecting infrared radiation emitted from the tympanic membrane. Classified as an infrared ear thermometer, it converts thermal energy into a digital temperature reading for rapid assessment of core body temperature, aiding in clinical and home health monitoring.
This device is intended for use in general hospital settings and is supplied as a reusable instrument. It has received FDA 510(k) clearance under the traditional review pathway, with a clearance type classified as substantially equivalent. The thermometer operates within the regulatory framework for medical thermometers, adhering to standards for accuracy and safety in temperature measurement.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK984551 | Date14 Jan 2000 | 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- Withdrawn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
Other devices from K-jump Health Co., Ltd.
Questions
Is the KI-8120 infrared ear thermometer designed for single-use or reusable in clinical settings?
The KI-8120 is explicitly supplied as a reusable instrument, meaning it is intended for repeated use in clinical environments like general hospitals. Since it is not labeled as disposable, proper cleaning and maintenance procedures must be followed to ensure accuracy and hygiene between uses.
What type of regulatory review pathway was followed for FDA clearance of this device, and what does that mean for its intended use?
The KI-8120 received FDA clearance under the traditional 510(k) review pathway, classified as *substantially equivalent* to a predicate device. This means the manufacturer demonstrated that the device has the same intended purpose and technological characteristics as an already-cleared infrared ear thermometer, ensuring compliance with safety and performance standards for measuring core body temperature in clinical settings.
How is the KI-8120 intended to be used in a hospital setting, and what does its advisory committee classification indicate?
The device is classified under the General Hospital (HO) advisory committee, which indicates its intended use is within standard hospital environments for rapid, non-contact temperature assessment via infrared detection of the tympanic membrane. This classification aligns with its role in clinical monitoring, where quick and accurate readings are critical for patient care.
Does the KI-8120 require any special storage conditions, and how should it be maintained for long-term use?
While the provided data does not specify storage conditions, as a reusable infrared ear thermometer, the KI-8120 should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its optical and electronic components. Regular calibration checks and adherence to manufacturer guidelines for cleaning and disinfection are essential for maintaining accuracy and functionality over repeated use.