# K180207: Non-contact Infrared Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Alicn Medical (Shenzhen), Inc.
- Decided: Nov 28, 2018 after 308 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 K011291 (2001). 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)
- K134043: NO Touch+Forehead NTF 3000 Thermometer, Kaz USA, Inc (A Subsidiaryof Kaz Inc) (2014) Summary page 5.

## Indications for use
Non-contact Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of two months and above of people by detecting infrared heat from the center of the forehead.

Source page: https://510kreport.com/device/K180207
Methodology: https://510kreport.com/methodology