# K202591: Body Infrared Thermometer HT-820D

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Xintai Instrument Co., Ltd.
- Decided: Mar 9, 2021 after 182 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182597: Infrared thermometer, Shenzhen Pango Electronic Co., Ltd. (2019) Summary page 4.

## Indications for use
The HT-820D Body Infrared Thermometer is intended to measure human body temperature by measuring the forehead from a distance of 5-8 cm. The device can be used on people of all ages in the home and professional healthcare facilities.

Source page: https://510kreport.com/device/K202591
Methodology: https://510kreport.com/methodology