# K033077: Easytem Duo, Forehead/Ear Thermometer, Model BT-021

- Pathway: 510(k) (Traditional)
- Applicant: Metatech Co., Ltd.
- Decided: Apr 30, 2004 after 214 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 K983295 (1999). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983295: Braun Thermoscan IRT3020/3500 One Secons Ear Thermometer, Model IRT3020/3520, Braun AG (1999) Summary page 1.
- K002712: Thermo Tek IR Forehead Thermometer, Model 718F, Saat, Ltd. (2001) Summary page 1.

## Most influential descendants
- K163256: Dual Mode Infrared Thermometer (2017), 0 descendants of its own

## Indications for use
This device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal or on the forehead in the neonatal, pediatric and adult population used at home.

Source page: https://510kreport.com/device/K033077
Methodology: https://510kreport.com/methodology