# K181215: Infrared Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Finicare Co., Ltd.
- Decided: Jan 2, 2019 after 240 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: 5 generations back to K010462 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171214: Infrared Thermometer, Shenzhen Brav Electronic Technologies Co., Ltd. (2018) Summary page 4.

## Indications for use
The Infrared Thermometer is intended for the measurement of human body temperatures. The forehead mode is indicated for people of all ages and the tympanic mode is indicated for people above three months old. The device can be used in the home setting and medical institutes.

Source page: https://510kreport.com/device/K181215
Methodology: https://510kreport.com/methodology