# K180387: Infrared Ear Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Hetaida Technology Co., Ltd.
- Decided: Jan 10, 2019 after 332 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: 1 generation back to K011059 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011059: Infared Ear Thermometer, Model TH8 Series, Radiant Innovation, Inc. (2001) Summary page 4.

## Indications for use
The Infrared Ear Thermometer, Model: HTD8208C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in people of all ages for home setting use.

Source page: https://510kreport.com/device/K180387
Methodology: https://510kreport.com/methodology