# K191283: Infrared Thermometer, Breeze model

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Melodicare Medical Technology Co., Ltd.
- Decided: Oct 18, 2019 after 158 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 K010462 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171214: Infrared Thermometer, Shenzhen Brav Electronic Technologies Co., Ltd. (2018) Summary page 4.

## Indications for use
The infrared thermometer is intended for the measurement and monitoring of human body temperature by physician or lay person. The device is not intended for infants less than three months.

Source page: https://510kreport.com/device/K191283
Methodology: https://510kreport.com/methodology