# K090395: Fora IR20B Ear Thermometer, Model TD-1261F, Fora IR21B Ear Thermometer, Model TD-1261E

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: Mar 10, 2009 after 21 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The FORA IR20b/FORA IR21b 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/K090395
Methodology: https://510kreport.com/methodology