# K191251: Infared Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Calibeur Industries Co., Ltd.
- Decided: Oct 15, 2019 after 159 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: 1 generation back to K171578 (2017). 1 ancestor in all.
14 later devices descend from it; 7 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171578: Infrared thermometer, Shenzhen Aeon Technology Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K200578: Infrared Thermometer Model Number RN-50A,RN-50B (2020), 5 descendants of its own
- K210086: Vitals360 Multi-Vitals Mobile Monitor (2021), 4 descendants of its own
- K212975: MedWand (2022), 1 descendant of its own
- K203707: Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 (2021), 1 descendant of its own
- K200471: Infrared Thermometer Model Number RN-60A,RN-60B (2020), 1 descendant of its own

## Indications for use
The Infrared thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.

Source page: https://510kreport.com/device/K191251
Methodology: https://510kreport.com/methodology