# K201864: YUWELL Infrared Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Decided: Dec 7, 2020 after 154 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: 5 generations back to K011291 (2001). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163516: Braun No Touch + Forehead NTF3000 Thermometer, Kaz USA, Inc., A Helen of Troy Company (2017) Summary page 4.

## Most influential descendants
- K211629: Infrared forehead thermometer LD-FT-100B (2021), 0 descendants of its own

## Indications for use
The YUWELL® Infrared thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non- contact mode on the center of the forehead as the measurement site on people of all ages except preterm babies.

Source page: https://510kreport.com/device/K201864
Methodology: https://510kreport.com/methodology