# K221800: Infrared Thermometer (Model: Y20001, Y20002)

- Pathway: 510(k) (Traditional)
- Applicant: Zhangzhou Easepal Medical Science and Technology Co., Ltd.
- Decided: Dec 14, 2022 after 176 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)
- K203170: Infrared Thermometer Models: DT-8806S, DT-8807S, Shenzhen Everbest Machinery Industry Co., Ltd. (2021) Summary page 5.

## Indications for use
The Infrared Thermometer (Model: Y20001, Y20002) is intended for the intermittent measurement and monitoring of human body temperature from forehead. The device is indicated for use for people of two months and above at homecare and in hospital.

Source page: https://510kreport.com/device/K221800
Methodology: https://510kreport.com/methodology