Basal Digital Thermometer
by K-jump Health Co., Ltd. 510(k)
Active
510(k) K141505
Overview
The Basal Digital Thermometer KD-2160 is an electronic clinical thermometer designed to measure human body temperature. It employs a thermistor sensor to detect temperature variations, converting these readings into a digital display for accurate assessment.
This device is intended for use in both home and healthcare settings, providing precise temperature readings for monitoring patients. Supplied as a single-use or reusable unit (as per manufacturer specifications), it adheres to FDA 510(k) clearance under predicate device classification FLL. The thermometer is non-magnetic and does not require special storage conditions beyond standard environmental parameters.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK141505 | Date26 Aug 2014 | 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- Withdrawn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
What types of settings can the Basal Digital Thermometer KD-2160 be used in, and how does its design support those environments?
The Basal Digital Thermometer KD-2160 is designed for use in both home and healthcare settings. Its electronic design with a digital display ensures precise temperature readings, which is critical for monitoring patients in clinical environments. The non-magnetic feature also makes it suitable for use near medical equipment that generates magnetic fields, such as MRI machines or other diagnostic tools. Its versatility allows it to be used flexibly depending on the clinical or homecare needs.
Is the Basal Digital Thermometer KD-2160 intended for single-use or reusable applications, and what does this mean for maintenance?
The Basal Digital Thermometer KD-2160 can be supplied as either a single-use or reusable unit, as specified by the manufacturer. If reusable, it must be cleaned and disinfected according to standard healthcare protocols to ensure hygiene and accuracy. Single-use units, on the other hand, eliminate the need for cleaning and maintenance, reducing the risk of cross-contamination but increasing disposal costs. The manufacturer’s instructions should be followed to determine the appropriate use case for your specific needs.
What storage requirements does the Basal Digital Thermometer KD-2160 have, and why are these important?
The Basal Digital Thermometer KD-2160 does not require special storage conditions beyond standard environmental parameters. This means it can be stored in typical room temperatures and humidity levels, making it convenient for both home and healthcare settings. Proper storage ensures the device remains accurate and functional, as extreme temperatures or humidity could potentially affect its performance over time.
How does the FDA clearance process apply to the Basal Digital Thermometer KD-2160, and what does the predicate device classification mean?
The Basal Digital Thermometer KD-2160 holds FDA 510(k) clearance, which means it has been determined to be substantially equivalent to a legally marketed predicate device. The predicate device classification is FLL (Fever, Low Temperature), indicating it is intended for measuring body temperature, particularly in the context of fever detection. This classification helps ensure the device meets regulatory standards for safety and effectiveness in its intended use.