# K211050: Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304

- Pathway: 510(k) (Traditional)
- Applicant: Jkh Health Co., Ltd.
- Decided: Nov 28, 2022 after 599 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
Infrared Thermometer is intended for forehead temperature measurement at home or hospital for people of all ages without contact to human body.

Source page: https://510kreport.com/device/K211050
Methodology: https://510kreport.com/methodology