# K020725: Microlife Digital Infrared Ear Thermometer, Model IR1DE1

- Pathway: 510(k) (Special)
- Applicant: Microlife Corp.
- Decided: Mar 12, 2002 after 6 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 K000969 (2000). 2 ancestors in all.
31 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000969: Microlife Digital Infrared Ear Thermometer, Model IR1DA1, Microlife Corp. (2000) Summary page 1.
- K003308: Microlife Digital Infrared Ear Thermometer, IR1DAI, IR1DB1, IR1DD1, Microlife Corp. (2000) Summary page 1.

## Most influential descendants
- K033820: Microlife Digital Infrared Forehead Thermometer, Model FR1DM1 (2004), 23 descendants of its own
- K100953: Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1 (2010), 18 descendants of its own
- K191829: Microlife Non-Contact Infrared Forehead Thermometer (2020), 11 descendants of its own
- K034023: Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1 (2004), 6 descendants of its own
- K150869: Checkme Pro Health Monitor (2015), 5 descendants of its own

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

Source page: https://510kreport.com/device/K020725
Methodology: https://510kreport.com/methodology