# K190873: Infrared Ear/Forehead Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Joytech Healthcare Co., Ltd.
- Decided: Jul 26, 2019 after 114 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.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181239: Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer, Joytech Healthcare Co., Ltd. (2018) Summary page 5.

## Most influential descendants
- K220276: Infrared Thermometer TET-351 (2023), 0 descendants of its own
- K202481: ThermArt (Model IR-EFT) (2021), 0 descendants of its own

## Indications for use
Infrared Ear/Forehead Thermometer DET-218 is intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.

Source page: https://510kreport.com/device/K190873
Methodology: https://510kreport.com/methodology