Talking Digital Thermometer, Model KV-171
by K-jump Health Co., Ltd. 510(k)
Active
510(k) K984553
Overview
The Talking Digital Thermometer, Model KV-171, is an electronic clinical thermometer designed to measure human body temperature via oral, rectal, or axillary routes. It provides digital temperature readings and features an integrated voice output to audibly announce results, enhancing accessibility for users.
This device is reusable and intended for use in general hospital settings. It is classified under product code FLL and has received FDA 510(k) clearance as substantially equivalent to a predicate device, with regulatory classification under 880.2910. No specific sterility or MRI safety information is provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK984553 | Date14 Jan 1999 | 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- Withdrawn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 routes of temperature measurement does the KV-171 support, and why might this matter for clinical use?
The KV-171 is designed for oral, rectal, and axillary (underarm) temperature measurement, providing flexibility for different patient populations and scenarios. Oral readings are common for adults, rectal for infants and precise readings, and axillary for non-invasive options. This versatility ensures compatibility with standard clinical protocols across age groups and settings.
Is the KV-171 a single-use or reusable device, and how does this impact its use in a hospital environment?
The KV-171 is explicitly labeled as reusable, which is ideal for hospital settings where cost efficiency and frequent use are priorities. Reusable devices reduce waste and allow for consistent use across multiple patients, provided proper cleaning and maintenance protocols are followed. However, hospitals must adhere to infection control guidelines to ensure safe reuse.
How does the voice-output feature of the KV-171 enhance accessibility for clinicians and patients?
The integrated voice output audibly announces temperature readings, which is particularly useful in noisy environments or for users with visual impairments. Clinicians can quickly verify readings without needing to interpret a display, and patients—especially those who are non-verbal or have limited English proficiency—can better understand their results. This feature aligns with accessibility standards in healthcare settings.
What regulatory pathway was followed for the KV-171, and what does this mean for its use in hospitals?
The KV-171 received FDA 510(k) clearance through a traditional review process, demonstrating it is substantially equivalent to a predicate device under product code FLL (thermometers). This classification means it meets U.S. safety and performance standards for general hospital use, as determined by the FDA’s review of its design, materials, and intended use. Hospitals can rely on this clearance as evidence of regulatory compliance.