# K163601: RII Smart IR Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Radiant Innovation, Inc.
- Decided: Dec 6, 2018 after 715 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 4.

## Indications for use
The RII Smart IR Thermometer, Model TMS-01A is a non-contact infrared forehead thermometer and can only be used with an APP since the display only on a device with the APP. It is intended for the intermittent measurement of human body temperatures and is to be used at home for people of all ages.

Source page: https://510kreport.com/device/K163601
Methodology: https://510kreport.com/methodology