# K121118: Fora Comfortscan Ear Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Foracare, Inc.
- Decided: Jun 15, 2012 after 64 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
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 use in the home. It is also available to detect object's surface temperature including human skin.

Source page: https://510kreport.com/device/K121118
Methodology: https://510kreport.com/methodology