Flexible Tip Digital Thermometer
by K-jump Health Co., Ltd. 510(k)
Active
510(k) K974195
Overview
A flexible tip digital thermometer designed for measuring body temperature in humans. This device falls under the classification of a digital clinical thermometer, featuring a flexible tip to enhance patient comfort during oral, rectal, or axillary temperature assessments. It provides precise readings via a digital display, ensuring accurate monitoring of vital signs.
The device is intended for use in both clinical and home settings, operated by healthcare professionals or patients. Non-sterile and reusable, it requires proper cleaning and maintenance between uses. Authorized under FDA 510(k) clearance (K974195), it adheres to regulatory standards for traditional premarket notification submissions. No additional sterility or MRI safety considerations are specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974195 | Date4 Feb 1998 | 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- Withdrawn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 temperature readings can this thermometer measure, and why is the flexible tip important for patient comfort?
This Flexible Tip Digital Thermometer is designed for oral, rectal, and axillary (underarm) temperature assessments. The flexible tip enhances patient comfort by adapting to different body contours, reducing discomfort during measurements—especially important for sensitive areas like the rectum or tight-fitting oral placements.
Is this thermometer meant for single-use or reusable applications, and what cleaning procedures should be followed?
The device is non-sterile and reusable, intended for repeated use in both clinical and home settings. Proper cleaning and maintenance between uses are required to ensure accuracy and hygiene, as outlined in the manufacturer’s instructions.
How does the regulatory approval process for this device differ from other medical thermometers?
This thermometer was cleared via a traditional FDA 510(k) submission (K974195), classified as substantially equivalent to a predicate device under the General Hospital (HO) advisory committee. The process involved demonstrating equivalence to existing digital clinical thermometers, rather than requiring a de novo pathway or premarket approval.
Can this thermometer be used in environments where MRI machines are present, and why?
There are no specified MRI safety considerations for this device in the provided data, meaning it should not be used near MRI machines unless confirmed safe by the manufacturer. Always verify compatibility with your facility’s MRI protocols to avoid interference or safety risks.