# K203583: YUWELL infrared ear thermometer: YHT101, YHT200

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Decided: May 20, 2021 after 163 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: 4 generations back to K031928 (2003). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152748: Braun Thermoscan PRO 6000 Ear Thermometer, Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) (2016) Summary page 4.

## Most influential descendants
- K250470: Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) (2025), 0 descendants of its own

## Indications for use
The YUWELL® Infrared ear thermometer is a non-sterile, reusable clinical thermometer. The device is to display the body temperature in the ear cavity by thermal radiation for people of all ages except preterm babies and newborns (1-29 days old).

Source page: https://510kreport.com/device/K203583
Methodology: https://510kreport.com/methodology