# K210118: INFRARED BODY THERMOMETER (Model: YK-001)

- Pathway: 510(k) (Traditional)
- Applicant: Longnan Renzhong Medical Equipment Co., Ltd.
- Decided: Sep 15, 2021 after 239 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 K010462 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131243: Non-Contact Infrared Thermometer, Shenzhen Jumper Medical Equipment Co., Ltd. (2013) Summary page 4.

## Indications for use
INFRARED BODY THERMOMETER (Model: YK-001) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature using the center of the forehead as the measurement site. The device is indicated for use by people over one month old. It can be used by consumers in household environment and doctors in clinic as reference.

Source page: https://510kreport.com/device/K210118
Methodology: https://510kreport.com/methodology