# K220084: Infrared Forehead Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Qingdao Yasee Medical Device Co., Ltd.
- Decided: Sep 12, 2022 after 245 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: 6 generations back to K011291 (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)
- K193253: Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503, Shenzhen Changkun Technology Co., Ltd. (2020) Summary page 4.

## Indications for use
Infrared Forehead Thermometers (modell: JA-11A; model2: JA-11S; model3: JA-11C) are non-sterile, reusable, non-contact and handheld devices. They can be used by consumers in homecare environment and doctors in clinic as reference. They are intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.

Source page: https://510kreport.com/device/K220084
Methodology: https://510kreport.com/methodology