# K103097: Infrared Ear Thermometer

- Pathway: 510(k) (Special)
- Applicant: Radiant Innovation, Inc.
- Decided: Dec 29, 2010 after 70 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: 1 generation back to K011059 (2001). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011059: Infared Ear Thermometer, Model TH8 Series, Radiant Innovation, Inc. (2001) Summary page 1.

## Most influential descendants
- K113833: Vital Signs Monitor (2012), 3 descendants of its own
- K153135: Vital Signs Monitor (2016), 2 descendants of its own
- K181919: Patient Monitor (2019), 0 descendants of its own
- K170538: RVS-100 Vital Signs Monitor (2017), 0 descendants 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 for intermittent monitoring of human body temperature in the home setting.

Source page: https://510kreport.com/device/K103097
Methodology: https://510kreport.com/methodology