# K034023: Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1

- Pathway: 510(k) (Special)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Jan 15, 2004 after 17 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: 2 generations back to K000969 (2000). 3 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020725: Microlife Digital Infrared Ear Thermometer, Model IR1DE1, Microlife Corp. (2002) Summary page 1.

## Most influential descendants
- K091040: Microlife Digital Infrared Ear Thermometer, Model Iridvi-1 (2009), 2 descendants of its own
- K170219: Microlife Digital Infrared Ear Thermometer (2017), 1 descendant of its own
- K113141: Microlife Dual Mode Thermometer,Model IFR1MJ1 (2012), 1 descendant of its own
- K182401: B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology (IRT) Thermometer probe, B.O.L.T Pulse Oximeter (SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter (2019), 0 descendants of its own
- K163256: Dual Mode Infrared Thermometer (2017), 0 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/K034023
Methodology: https://510kreport.com/methodology