# K200159: Non-contact Infrared Body Thermometer, model:HTD8823US

- Pathway: 510(k) (Traditional)
- Applicant: Hetaida Technology Co., Ltd.
- Decided: Jan 5, 2021 after 349 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 K011291 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163516: Braun No Touch + Forehead NTF3000 Thermometer, Kaz USA, Inc., A Helen of Troy Company (2017) Summary page 4.
- K011291: Temporalscanner Thermometer, Sensortouch, Exergen Corp. (2001) Summary page 5.

## Indications for use
The Infrared Body Thermometer, Model: HTD8823US, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead in people of all ages for home setting use.

Source page: https://510kreport.com/device/K200159
Methodology: https://510kreport.com/methodology