# K200781: Infrared Body Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Heitaida Technology Co., Ltd.
- Decided: Dec 9, 2020 after 273 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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.
- K152748: Braun Thermoscan PRO 6000 Ear Thermometer, Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) (2016) Summary page 5.

## Indications for use
The Infrared Body Thermometer, Model: HTD8222US, is an electronic clinical thermometer using an infrared sensor for the intermittent determination of body temperature from the forehead and auditory canal in people of all ages for home setting use.

Source page: https://510kreport.com/device/K200781
Methodology: https://510kreport.com/methodology