# K063185: Rii Infrared Ear Thermometer, Models TH5XY Series

- Pathway: 510(k) (Special)
- Applicant: Radiant Innovation, Inc.
- Decided: Nov 17, 2006 after 28 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 K011059 (2001). 4 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051269: Rii Infrared Ear Thermometer, Models TH00XY Series, Radiant Innovation, Inc. (2005) Summary page 1.

## Most influential descendants
- K162083: RII Multi-function Infrared Thermometer, Model TH52Z (2017), 14 descendants of its own
- 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

## Indications for use
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

Source page: https://510kreport.com/device/K063185
Methodology: https://510kreport.com/methodology