# K190984: Infrared Forehead Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Xiamen Ants Bro Technology Co., Ltd.
- Decided: Apr 22, 2020 after 373 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)
- K181242: Braun BNT400 No Touch + Forehead Thermometer, Kaz USA, Inc., A Helen of Troy Company (2018) Summary page 4.

## Indications for use
Infrared Forehead Thermometer (Models: HA-610, HA-620, HA-630, HA-640, HA-650) is a non-sterile, reusable, clinical thermometer intended for the intermittent determination of human body temperature in a touch and no touch mode using the center of the forehead as the measurement site on people of all ages. The devices are reusable for home use only.

Source page: https://510kreport.com/device/K190984
Methodology: https://510kreport.com/methodology