# K200802: Infrared Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Urion Technology Co., Ltd.
- Decided: Oct 7, 2020 after 194 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 thermometer (model of UFR102) is intended for measurement of ear and forehead temperature. It can be used for anybody, e.g. for new-born, for children and for adults. The infrared non-contact thermometer (model of UFR106 and UFR107) is intended for measurement forehead temperature at home and hospital, for patients of all ages.

Source page: https://510kreport.com/device/K200802
Methodology: https://510kreport.com/methodology