# K202741: Infrared Forehead Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Combei Technology Co., Ltd.
- Decided: Jul 7, 2021 after 292 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 K000969 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191829: Microlife Non-Contact Infrared Forehead Thermometer, Microlife Intellectual Property GmbH (2020) Summary page 5.

## Indications for use
Infrared Forehead Thermometer is intended for the intermittent measurement and monitoring of forehead temperature. The device is indicated for use by people of all ages in the home.

Source page: https://510kreport.com/device/K202741
Methodology: https://510kreport.com/methodology