# K202368: Infrared Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Bittel Intelligent Technology Co., Ltd.
- Decided: Feb 12, 2021 after 177 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: 2 generations back to K171578 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191251: Infared Thermometer, Shenzhen Calibeur Industries Co., Ltd. (2019) Summary page 5.

## Indications for use
The Infrared thermometer is non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all age. The device is reusable for home use and clinical use

Source page: https://510kreport.com/device/K202368
Methodology: https://510kreport.com/methodology