# K081445: Fora Comfortscan Ear Thermometer, Models TD-1261A; TD-1261B

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Aug 11, 2008 after 81 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: 1 generation back to K061800 (2006). 1 ancestor in all.
13 later devices descend from it; 5 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061800: Clever TD-1112 Ear/Skin/Surface IR Thermometer, Taidoc Technology Corporation (2006) Summary page 1.

## Most influential descendants
- K113159: U-Right TD-1240 Thermometer (2012), 7 descendants of its own
- K131771: Caregiver Professional Clinical Thermometer, Pro-TF Series (2013), 2 descendants of its own
- K122221: Nexus IR30 Non-Contact Infrared Forehead Thermometer (2013), 2 descendants of its own
- K101259: V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002 (2010), 1 descendant of its own
- K200946: Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241) (2022), 0 descendants of its own

## 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 and for use in the home. It is also available to detect object's surface temperature including human skin.

Source page: https://510kreport.com/device/K081445
Methodology: https://510kreport.com/methodology