# K063291: Infrared Ear Thermometer, Model Irt-21 and Irt-22

- Pathway: 510(k) (Traditional)
- Applicant: Choice Smart Health Care Co., Ltd.
- Decided: Nov 21, 2006 after 20 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 K010383 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010383: Temp Scan, Tenghi Co., Ltd. (2001) Summary page 3.

## Indications for use
Infrared Ear Thermometer (IRT-21 and IRT-22), designed with infrared technology, is used to measure body temperature from ear canal. Press the ON/OFF button to turn on the power, insert the probe into the ear canal then press the SCAN button to measure the temperature, when you hear a beep sound, the measurement is complete. Infrared Ear Thermometer (IRT-21 and IRT-22) is intended for household and hospital use on people of all ages.

Source page: https://510kreport.com/device/K063291
Methodology: https://510kreport.com/methodology