# K250878: YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Decided: May 22, 2025 after 59 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.
No later device cites it as a predicate yet.
0 of 5 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 5.

## Indications for use
The Infrared Ear Thermometer is indicated for intermittent measurement of human body temperature from the ear canal. The device can be used by people of all ages except preterm babies or babies who are small for gestational age. The thermometer is intended for use in professional settings and the home environment. It is not for emergency clinical conditions.

Source page: https://510kreport.com/device/K250878
Methodology: https://510kreport.com/methodology