# K111637: Infrared Ear Thermometer

- Pathway: 510(k) (Special)
- Applicant: Radiant Innovation, Inc.
- Decided: Dec 6, 2011 after 176 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
No predicates in its family tree.
5 later devices descend from it; 2 cite 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)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K0011059: Radiant Innovation Infrared Ear Thermometer, Models TH8 series. Number could not be read

## Most influential descendants
- K120144: Vital Signs Monitor (2012), 2 descendants of its own
- K140681: Belter Infra-Red Ear Thermometer (2014), 1 descendant of its own
- K131818: Vital Signs Monitor (2013), 1 descendant of its own
- K180380: vital signs monitor (2018), 0 descendants of its own
- K180314: Infrared Thermometer (2018), 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 in the home setting.

Source page: https://510kreport.com/device/K111637
Methodology: https://510kreport.com/methodology