Kingtech Forehead Thermometer
by Kingtech Enterprise, Ltd. 510(k)
Active
510(k) K133113
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK133113 | Date26 Dec 2013 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Overview
AI-generated summary, 19 Sep 2026
The Kingtech Forehead Thermometer TF1265 is a non-contact electronic thermometer classified as a Forehead Thermometer (Product Code: FLL) under 21 CFR 880.2910. It employs an infrared sensor to measure body temperature by detecting thermal radiation emitted from the forehead, providing rapid readings without physical contact.
This device is intended for home use and is supplied as a single-use or reusable unit (specific reuse instructions are detailed in the manufacturer’s manual). It is not designed for MRI environments and requires proper storage to maintain accuracy. The device holds FDA 510(k) clearance (K133113) as substantially equivalent to a predicate device, ensuring compliance with regulatory standards for non-invasive temperature measurement.
Other devices from Kingtech Enterprise, Ltd.
Questions
AI-generated answers, 19 Sep 2026
Can this thermometer be used repeatedly, or is it meant for single-use only?
The Kingtech Forehead Thermometer TF1265 is designed to function as either a single-use or reusable device, depending on the user’s preference. The manufacturer provides specific reuse instructions in the included manual to ensure proper cleaning and maintenance if the reusable option is chosen. This flexibility accommodates different clinical or home-use scenarios where hygiene and convenience are prioritized.
How does the infrared sensor technology in this thermometer work, and why is it considered non-contact?
The Kingtech Forehead Thermometer TF1265 uses an infrared sensor to detect thermal radiation emitted from the forehead, measuring body temperature without physical contact. This non-contact method eliminates the need for direct skin contact, reducing the risk of cross-contamination and allowing for rapid readings—ideal for quick assessments in home or clinical settings.
What storage conditions are required to ensure the thermometer maintains its accuracy over time?
To preserve accuracy, the Kingtech Forehead Thermometer TF1265 should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. Avoiding exposure to these factors helps prevent sensor degradation or calibration drift, ensuring reliable performance when needed for temperature measurements.
Is this device suitable for use in environments where MRI machines are present, and why or why not?
No, the Kingtech Forehead Thermometer TF1265 is explicitly not designed for use in MRI environments. The device contains electronic components and materials that could be affected by magnetic fields or radiofrequency interference generated during MRI procedures, potentially compromising its functionality or safety.
What regulatory pathway was followed for FDA clearance, and what does ‘substantially equivalent’ mean in this context?
The Kingtech Forehead Thermometer TF1265 received FDA clearance through a 510(k) premarket notification process, specifically under the Traditional Review pathway. The ‘substantially equivalent’ designation (decision code: SESE) means the device was determined to have the same intended use, technological characteristics, and performance as a legally marketed predicate device (in this case, a comparable forehead thermometer). This classification ensures compliance with regulatory standards for non-invasive temperature measurement.