# K160999: Infra-red forehead thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Hua'An Medical&Health Instruments Co.,Ltd
- Decided: Aug 1, 2016 after 112 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The devices models FT-100A FT-100B FT-100D FT-100E are electronic clinical thermometer intended to measure human body temperature in people of all ages, its operation is based on measuring the natural thermal radiation emanating from the forehead.

Source page: https://510kreport.com/device/K160999
Methodology: https://510kreport.com/methodology