# K202111: Medical infrared forehead thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Honggao Electronic Technolofy Co., Ltd.
- Decided: Feb 26, 2021 after 211 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
The Medical infrared forehead thermometer (Model: HGO1, HGO1 Vl, HGO6 ) is a non-contact thermometer intended for the intermittent measurement of human body temperature from forehead for people of one year old and above. The device is reusable for home use and clinical use.

Source page: https://510kreport.com/device/K202111
Methodology: https://510kreport.com/methodology