# K100942: U-Right Ear Themometer, Models TD-1115 and TD-1118

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: May 26, 2010 after 51 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 U-RIGHT TD-1 1115 ear thermometer and UI-RIGHT Tb-hi 8 ear thermometer are intended for the intermittent measurement and monitoring of human body temperature from ear canal. The devices are indicated for use by people of all ages in the home.

Source page: https://510kreport.com/device/K100942
Methodology: https://510kreport.com/methodology