# K203497: Infrared Thermometer (Model K9)

- Pathway: 510(k) (Traditional)
- Applicant: Kangzhan Communication Electronics Co., Ltd.
- Decided: Oct 8, 2021 after 315 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 K011291 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191668: Infrared Forehead Thermometer (Model IR-FT), Comper Chuangxiang (Beijing) Technology Co., Ltd. (2019) Summary page 5.

## Indications for use
The Infrared Thermometer, Model K9 is a non-contact infrared thermometer intended for the intermittent measurement and monitoring of human body temperature from forehead for clinical and home use environments. It can be used for anybody, e.g. for infant, children and adults (Excluding neonates). The device does not require sterilization and can be reused.

Source page: https://510kreport.com/device/K203497
Methodology: https://510kreport.com/methodology