# K210014: Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)

- Pathway: 510(k) (Traditional)
- Applicant: Guandong Genial Technology Co., Limited
- Decided: Jun 4, 2021 after 151 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: 5 generations back to K011291 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173048: No-contact Forehead Thermometer, Dongguan Simzo Electronic Technology Co., Ltd. (2018) Summary page 5.

## Indications for use
The Infrared Forehead Thermometer (Model: T80, T81. T82, T83., T84. T85) is a non-contact thermometer used to measurement forehead temperature at home or hospital. The device is indicated for use on people of all ages except for neonates/newborns.

Source page: https://510kreport.com/device/K210014
Methodology: https://510kreport.com/methodology