Digital Clinical Thermometer Model KD-193
by K-jump Health Co., Ltd. 510(k)
Active
510(k) K021851
Overview
The Digital Clinical Thermometer Model KD-193 is a digital device classified as a clinical thermometer, designed to measure human body temperature. It employs an electronic transducer to convert thermal input into a digital signal, which is then amplified, processed, and displayed for accurate reading.
This device is intended for single-use or reusable clinical settings, with oral, rectal, or axillary measurement capabilities. It operates in predictive or regular mode and has received FDA 510(k) clearance under the product code FLL. The device is supplied sterile or non-sterile as specified by the manufacturer and must be handled according to standard infection control protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK021851 | Date17 Jul 2002 | 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- Withdrawn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
What temperature measurement sites does the KD-193 support, and how does that affect its use in different clinical settings?
The KD-193 is designed for oral, rectal, and axillary (underarm) temperature measurements, making it versatile for general clinical use. Oral readings are common for adults, rectal measurements are often used for infants and young children, and axillary readings provide a non-invasive alternative when oral or rectal methods are impractical. This flexibility allows clinicians to choose the most appropriate site based on patient age, condition, and comfort.
Is the KD-193 intended for single-use or reusable applications, and what does that mean for infection control?
The KD-193 is specified for both single-use and reusable clinical settings, meaning it can be used once and discarded or cleaned and reused according to facility protocols. For reusable use, strict adherence to infection control guidelines—such as sterilization or high-level disinfection—is required to prevent cross-contamination between patients. Single-use units eliminate reprocessing steps but may incur higher waste costs.
How does the KD-193’s sterility status impact its handling, and what should buyers consider when ordering?
The KD-193 is available in sterile or non-sterile configurations, as determined by the manufacturer. Sterile units are pre-packaged and ready for immediate use, reducing the risk of contamination during measurement, while non-sterile units require reprocessing before reuse. Buyers should specify their preferred sterility status when ordering to ensure compliance with infection control policies and minimize waste or reprocessing burdens.
What operational modes does the KD-193 offer, and how might that influence its selection for a specific clinical workflow?
The KD-193 operates in predictive or regular mode, which likely refers to features like predictive temperature stabilization (faster readings) or standard measurement modes. Predictive mode could be advantageous in fast-paced settings where quick results are critical, such as emergency departments or pediatric clinics, while regular mode may suffice for routine outpatient measurements. Clinicians should consider their workflow demands when choosing between models.
What regulatory pathway was followed for FDA clearance of the KD-193, and what does that mean for its compliance requirements?
The KD-193 received FDA 510(k) clearance under the product code FLL (Clinical Thermometers) via an abbreviated review process, determined to be *substantially equivalent* to a predicate device. This means it meets FDA standards for safety and effectiveness as outlined in the 510(k) submission, but buyers should confirm compliance with current FDA guidelines, including labeling requirements and infection control protocols, as regulations may evolve.