# K132457: Fora Diamond Nexus Mini Infrared Forehead Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Biocare Asia Corporation, Ltd.
- Decided: Feb 21, 2014 after 199 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: 3 generations back to K061800 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113159: U-Right TD-1240 Thermometer, Taidoc Technology Corporation (2012) Summary page 1.

## Indications for use
FORA Diamond Nexus Mini Infrared Forehead Thermometer is intended for the intermittent measurement and monitoring of human body temperature from forehead measurement at home.

Source page: https://510kreport.com/device/K132457
Methodology: https://510kreport.com/methodology