# K120712: Fora Comfortscan Ear Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Jun 6, 2012 after 90 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 K061800 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081445: Fora Comfortscan Ear Thermometer, Models TD-1261A; TD-1261B, Taidoc Technology Corporation (2008) Summary page 2.

## Indications for use
The Fora ComfortScan Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages for home and professional use.

Source page: https://510kreport.com/device/K120712
Methodology: https://510kreport.com/methodology