# K081788: Infrared Ear Thermometer, Models Innotherm Ict-100 and Ict-200

- Pathway: 510(k) (Traditional)
- Applicant: Innochips Technology Co., Ltd.
- Decided: Dec 17, 2008 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
Longest line of descent: 1 generation back to K011059 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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
- K111703: Infrared Ear Therometer (2012), 0 descendants of its own

## Indications for use
Infrared Ear Thermometer (InnoTherm ICT-100 and InnoTherm ICT-200) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.

Source page: https://510kreport.com/device/K081788
Methodology: https://510kreport.com/methodology