# K180314: Infrared Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Xuzhou Yongkang Electronic Science Technology Co., Ltd.
- Decided: Jul 11, 2018 after 156 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: 2 generations back to K111637 (2011). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140681: Belter Infra-Red Ear Thermometer, Shenzhen Belter Health Measurement and Analysis TE (2014) Summary page 7.

## Indications for use
The Infrared thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages for home and professional use.

Source page: https://510kreport.com/device/K180314
Methodology: https://510kreport.com/methodology