# K020504: Infrared Ear Thermometer, Models TH88 Series

- Pathway: 510(k) (Special)
- Applicant: Radiant Innovation, Inc.
- Decided: Feb 28, 2002 after 13 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.
No later device cites it as a predicate yet.
0 of 2 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.

## 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/K020504
Methodology: https://510kreport.com/methodology