# K160802: Infrared Forehead Thermometer, FT-100A

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Universal Electronic Co., Ltd.
- Decided: Aug 24, 2016 after 154 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: 4 generations back to K061800 (2006). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122221: Nexus IR30 Non-Contact Infrared Forehead Thermometer, Taidoc Technology Corporation (2013) Summary page 4.

## Indications for use
The FT-100A Electronic thermometer is an Infrared thermometer which uses an infrared sensor to detect human body temperature of patients of all ages. It is intended to be used on forehead to detect body temperature. The FT-100A is intended for home use.

Source page: https://510kreport.com/device/K160802
Methodology: https://510kreport.com/methodology