# K162509: Infrared Non-contact Thermometer, Model ACT8100

- Pathway: 510(k) (Traditional)
- Applicant: Easywell Biomedicals, Inc.
- Decided: Mar 10, 2017 after 183 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 K011291 (2001). 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)
- K134043: NO Touch+Forehead NTF 3000 Thermometer, Kaz USA, Inc (A Subsidiaryof Kaz Inc) (2014) Summary page 4.

## Indications for use
The Infrared Non-Contact Thermometers, ACT8100, is non-sterile, reusable clinical thermometers intended for the intermittent determination of human body temperature measured at the center of the forehead without contact. The device is intended for use on people of all ages, except pre-term babies or very small (small for gestational age). The device is intended for use in clinical and home use environments.

Source page: https://510kreport.com/device/K162509
Methodology: https://510kreport.com/methodology