# K203656: Non-Contact Forehead Thermometer (UT30H)

- Pathway: 510(k) (Traditional)
- Applicant: Uni-Trend Technology (China) Co., Ltd.
- Decided: Jan 22, 2021 after 38 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: 2 generations back to K171578 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191251: Infared Thermometer, Shenzhen Calibeur Industries Co., Ltd. (2019) Summary page 5.

## Indications for use
The Non-Contact Forehead Thermometer (Model: UT30H) is a reusable, infrared thermometer intended for the intermittent measurement of human body temperature on the forehead of people of all ages. It can be used by consumers in the home environment and doctors in the clinic environment as reference.

Source page: https://510kreport.com/device/K203656
Methodology: https://510kreport.com/methodology