# K101253: Rii Infrared Ear Thermometer, Model: TH60N

- Pathway: 510(k) (Special)
- Applicant: Radiant Innovation, Inc.
- Decided: Jun 29, 2010 after 56 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: 6 generations back to K011059 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070976: Rii Infrared Ear Thermometer, Model TH01BN, Radiant Innovation, Inc. (2007) Summary page 1.

## 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/K101253
Methodology: https://510kreport.com/methodology