# K202440: Infrared Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Sonida Digital Technology Co., Ltd.
- Decided: Jun 17, 2021 after 296 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: 7 generations back to K011059 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191570: Infrared Thermometer Model MD-H30, Guangzhou Berrcom Medical Device Co., Ltd. (2019) Summary page 5.

## Indications for use
The infrared thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It can be used by consumers in the household environment and by healthcare providers.

Source page: https://510kreport.com/device/K202440
Methodology: https://510kreport.com/methodology