# K160816: Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)

- Pathway: 510(k) (Traditional)
- Applicant: Nexmed Technology Co., Ltd.
- Decided: Sep 21, 2016 after 181 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: 6 generations back to K010462 (2001). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131243: Non-Contact Infrared Thermometer, Shenzhen Jumper Medical Equipment Co., Ltd. (2013) Summary page 5.

## Most influential descendants
- K153600: Consult Station TS (2017), 0 descendants of its own

## Indications for use
Infrared Thermometer is intended for body temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.

Source page: https://510kreport.com/device/K160816
Methodology: https://510kreport.com/methodology