Non-Contact Thermometer
by K-jump Health Co., Ltd. Taiwan 510(k)
510(k) K120711
Product code FLL
Overview
This device is a Non-Contact Infrared Thermometer, classified under product code FLL, designed to measure body temperature without physical contact. It utilises infrared technology to detect thermal radiation emitted from the forehead or other body surfaces, providing rapid and non-invasive temperature readings for clinical or home use.
The KI-8271 is supplied as a single-use or reusable device (as per manufacturer specifications) and is intended for use in general hospital settings. It is not classified as MRI-safe or sterile upon delivery but may be cleaned and disinfected for reuse where applicable. Authorised under FDA 510(k) clearance (K120711) as substantially equivalent to existing devices, it adheres to regulatory standards for non-contact thermometry in medical environments.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120711 | Date19 Nov 2012 | StatusActive |
Coverage
- Active
- 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 thermometer work, and what body parts can it measure temperature from?
The device uses infrared technology to detect thermal radiation emitted from the body, allowing it to measure temperature without physical contact. It is specifically designed to read temperatures from the forehead or other body surfaces, making it ideal for rapid, non-invasive assessments in clinical or home settings.
Is this thermometer reusable, and if so, what cleaning or disinfection procedures should be followed?
The KI-8271 model can be used either as a single-use or reusable device, depending on manufacturer specifications. If reused, it should be cleaned and disinfected according to standard medical device protocols to ensure hygiene and prevent cross-contamination in hospital settings.
What types of environments is this thermometer intended for, and does it require any special handling upon arrival?
This device is authorized for use in general hospital settings and is not sterile upon delivery. It is not MRI-safe, so it should not be used in MRI environments. Proper cleaning and disinfection may be required for reuse, depending on the model and facility protocols.
What regulatory pathway was followed for FDA clearance, and what does 'substantially equivalent' mean in this context?
The device received FDA clearance through a traditional 510(k) review process, classified as substantially equivalent (SESE) to existing non-contact thermometers. This means the FDA determined it has the same intended use and technological characteristics as legally marketed devices, ensuring compliance with regulatory standards for non-contact thermometry.
Are there different models or sizes available for this non-contact thermometer, and how should it be stored?
The data provided does not specify multiple models or sizes beyond the KI-8271 designation, which is the primary reference. Storage instructions are not detailed, but generally, such devices should be kept in a clean, dry environment away from direct sunlight or extreme temperatures to maintain accuracy and functionality.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K120711