# K133113: Kingtech Forehead Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Kingtech Enterprise, Ltd.
- Decided: Dec 26, 2013 after 87 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K061800 (2006). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122221: Nexus IR30 Non-Contact Infrared Forehead Thermometer, Taidoc Technology Corporation (2013) Summary page 1.

## Indications for use
TF1265 and TF1267 Forehead Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the surface of human skin without contact. It is for use by people of all ages in the homecare environment.

Source page: https://510kreport.com/device/K133113
Methodology: https://510kreport.com/methodology