# K162083: RII Multi-function Infrared Thermometer, Model TH52Z

- Pathway: 510(k) (Traditional)
- Applicant: Radiant Innovation, Inc.
- Decided: Jan 9, 2017 after 166 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: 5 generations back to K011059 (2001). 9 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063185: Rii Infrared Ear Thermometer, Models TH5XY Series, Radiant Innovation, Inc. (2006) Summary page 4.
- K121428: Non-Contact Clinical Thermometer, Radiant Innovation, Inc. (2012) Summary page 5.

## Most influential descendants
- K191570: Infrared Thermometer Model MD-H30 (2019), 8 descendants of its own
- K181239: Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer (2018), 3 descendants of its own
- K190873: Infrared Ear/Forehead Thermometer (2019), 2 descendants of its own
- K213011: Infrared Thermometer (model: E201) (2022), 1 descendant of its own
- K200531: iHealth Infrared No-Touch Forehead Thermometer (2020), 1 descendant of its own

## Indications for use
The RII Multi-function Infrared Thermometer, Model TH52Z is intended for the intermittent measurement of human body temperatures. The device is intended for the use at home by people of all ages including neonates and it can be selected Ear mode or Forehead mode.

Source page: https://510kreport.com/device/K162083
Methodology: https://510kreport.com/methodology