# K201579: Infrared Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Xunwei Industrial Co., Ltd.
- Decided: Jan 15, 2021 after 218 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 K000969 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191829: Microlife Non-Contact Infrared Forehead Thermometer, Microlife Intellectual Property GmbH (2020) Summary page 5.

## Indications for use
The infrared thermometer, Model XW-60 is intended for the intermittent measurement and monitoring of forehead temperature of human body. The device is indicated for use by people of one month old and above age in the home.

Source page: https://510kreport.com/device/K201579
Methodology: https://510kreport.com/methodology