# K181081: Infrared Ear Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Joytech Healthcare Co., Ltd.
- Decided: Oct 2, 2018 after 161 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: 3 generations back to K031928 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153146: Infrared Ear Thermometer, Sejoy Electronics & Instruments Co., Ltd. (2016) Summary page 5.

## Indications for use
Infrared Ear Thermometers 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/K181081
Methodology: https://510kreport.com/methodology