# K240648: Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)

- Pathway: 510(k) (Traditional)
- Applicant: Radiant Innovation, Inc.
- Decided: Jun 5, 2024 after 90 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)
- K121428: Non-Contact Clinical Thermometer, Radiant Innovation, Inc. (2012) Summary page 5.

## Indications for use
The non-contact forehead thermometer is an electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from forehead center in people of all ages.

Source page: https://510kreport.com/device/K240648
Methodology: https://510kreport.com/methodology