# K213082: Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Berrcom Medical Device Co., Ltd.
- Decided: Jan 28, 2022 after 127 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: 6 generations back to K011291 (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)
- K180355: Advocate Non-Contact Infrared Thermometer, Broadmaster Biotech, Corp. (2019) Summary page 5.

## Indications for use
The Non-Contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311, is a non-sterile, reusable, handheld device. It can be used by consumers in household environment and doctor in clinic as reference. It is intended for non-contact measuring of human body temperature of people of all ages (neonate, infant, pediatric, adult) by detecting infrared heat from the center of the forehead.

Source page: https://510kreport.com/device/K213082
Methodology: https://510kreport.com/methodology