# K111703: Infrared Ear Therometer

- Pathway: 510(k) (Traditional)
- Applicant: Fudakang Industrial Co., Ltd.
- Decided: Mar 29, 2012 after 286 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: 2 generations back to K011059 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081788: Infrared Ear Thermometer, Models Innotherm Ict-100 and Ict-200, Innochips Technology Co., Ltd. (2008) Summary page 1.
- K101912: The Infrared Forehead Thermometer, Model FS-300&301, Hubdic Co., Ltd. (2010) Summary page 1.

## Indications for use
Infrared Thermometer (FT-F11) 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. Infrared Thermometer, (FT-F21, FT-F31, FT-F41) is intended for intermittent measurement of human body temperature in people of all ages.

Source page: https://510kreport.com/device/K111703
Methodology: https://510kreport.com/methodology