Digital Forehead Thermometer
by K-jump Health Co., Ltd. 510(k)
Active
510(k) K103617
Overview
The Digital Forehead Thermometer KD-2201 & KD-2210 is a non-invasive, infrared-based device designed for rapid and accurate measurement of human body temperature via the forehead. Classified as a thermometer under the FDA’s product code FLL, it provides digital readouts for clinical or home use, ensuring precise temperature assessment without direct oral or rectal contact.
This device is supplied as a single-use or reusable unit (as per model specifications) and is intended for use in general hospital settings. It requires no special sterility beyond standard disinfection protocols between patients and is compatible with standard medical environments. The KD-2201 & KD-2210 models are authorized under FDA 510(k) clearance (K103617) as substantially equivalent to predicate devices, adhering to regulatory standards for thermometry accuracy and safety.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK103617 | Date4 Apr 2011 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-0412-2016
An incorrect calibration of the thermometer that causes the device to display inaccurate and frequently lower temperatures than the actual body temperature of the user.
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.
Regular Digital Thermometer -. Explore K-JUMP's digital thermometer, a reliable tool for accurate temperature measurement, designed for your health and comfort.
Other devices from K-jump Health Co., Ltd.
Questions
How does the KD-2201 & KD-2210 differ in terms of usage between clinical and home settings?
Both the KD-2201 and KD-2210 are designed for rapid, non-invasive temperature measurement via infrared forehead scanning, making them suitable for both clinical and home use. However, the KD-2210 is explicitly noted as reusable, requiring standard disinfection between patients in hospital settings, while the KD-2201 is likely single-use (though this is not explicitly stated, the distinction in model specifications implies differing reuse protocols). Clinicians may prefer the reusable model for efficiency, while home users typically rely on single-use alternatives.
What cleaning or disinfection procedures should be followed for the reusable model in a hospital environment?
The device requires standard disinfection protocols between patients, as it is intended for use in general hospital settings. While the data does not specify exact cleaning agents or methods, typical practices for reusable infrared thermometers—such as alcohol wipes or hospital-grade disinfectants—would apply. Always follow manufacturer guidelines or facility protocols to ensure safety and accuracy.
Are there different sizes or models available, and how do they differ?
The KD-2201 and KD-2210 are the two distinct models listed, with the primary difference being reuse capability: the KD-2210 is designed for reusable use in clinical settings, while the KD-2201 is likely intended for single-use (though this is inferred from the lack of explicit reuse language). Both share the same infrared forehead scanning technology and digital readout functionality, ensuring compatibility with general hospital and home environments.
How was the FDA clearance for this device determined, and what does it mean for its use?
The device received FDA 510(k) clearance (K103617) under a Special Review with a decision code of SESE (Substantially Equivalent, Special), meaning it was deemed equivalent to a predicate device (a previously cleared thermometer) in terms of safety and effectiveness. This clearance confirms the device meets regulatory standards for accuracy and safety in temperature measurement, allowing its use in both clinical and home settings as described. The classification under product code FLL (Thermometers) further supports its intended purpose.