# K203454: Infrared Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Zhushi Pharmaceutical Group Co., Ltd.
- Decided: Apr 29, 2021 after 157 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 Thermometer (model: ZST-A) is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is 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/K203454
Methodology: https://510kreport.com/methodology