# K211629: Infrared forehead thermometer LD-FT-100B

- Pathway: 510(k) (Traditional)
- Applicant: Honsun (Nantong) Co., Ltd.
- Decided: Dec 8, 2021 after 195 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)
- K201864: YUWELL Infrared Thermometer, Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. (2020) Summary page 4.

## Indications for use
The infrared forehead thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non-contact mode on the center of the forehead as the measurement site on people of all ages except the age under the 1 year.

Source page: https://510kreport.com/device/K211629
Methodology: https://510kreport.com/methodology