# K181239: Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Joytech Healthcare Co., Ltd.
- Decided: Oct 29, 2018 after 172 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 K011059 (2001). 10 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K121428: Non-Contact Clinical Thermometer, Radiant Innovation, Inc. (2012) Summary page 4.
- K162083: RII Multi-function Infrared Thermometer, Model TH52Z, Radiant Innovation, Inc. (2017) Summary page 5.

## Most influential descendants
- K190873: Infrared Ear/Forehead Thermometer (2019), 2 descendants of its own
- 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 Thermometer DET series are 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/K181239
Methodology: https://510kreport.com/methodology