# K112189: Thermo Pal Infrared Ear Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Digio2 International Co., Ltd.
- Decided: Jan 13, 2012 after 168 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: 3 generations back to K031928 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103800: Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Clinical Infrared Ear Thermometers, Kaz USA, Inc (A Subsidiaryof Kaz Inc) (2011) Summary page 1.

## Indications for use
The Thermo Pal Infrared Ear Thermometer (Model no.: ETH-l0l) is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.

Source page: https://510kreport.com/device/K112189
Methodology: https://510kreport.com/methodology