# K191668: Infrared Forehead Thermometer (Model IR-FT)

- Pathway: 510(k) (Traditional)
- Applicant: Comper Chuangxiang (Beijing) Technology Co., Ltd.
- Decided: Oct 18, 2019 after 119 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.
1 later device descends from it; 1 cites it directly.
0 of 6 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 4.

## Most influential descendants
- K203497: Infrared Thermometer (Model K9) (2021), 0 descendants of its own

## Indications for use
This device is a non-sterile, reusable, contact Infrared Forehead Thermometer (Model IR-FT) intended for intermittent determination of human body temperature through a touch on the center of the forehead as the measurement site on people of all ages. The Infrared Forehead Thermometer (Model IR-FT) can be used in clinical and home environments.

Source page: https://510kreport.com/device/K191668
Methodology: https://510kreport.com/methodology