# K201843: Infrared ear and forehead thermometer, model YI-100

- Pathway: 510(k) (Traditional)
- Applicant: Wenzhou Yosun Medical Technology Co.,Ltd
- Decided: Oct 23, 2020 after 109 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Infrared ear and forehead thermometer model YI-100 is a multi-function infrared thermometer intended for the intermittent measurement of human body temperature by Ear mode, or by Forehead mode (moving the thermometer head from one temple to another temple for forehead measurement). The device can be used on people of one month old and above.

Source page: https://510kreport.com/device/K201843
Methodology: https://510kreport.com/methodology