# K091040: Microlife Digital Infrared Ear Thermometer, Model Iridvi-1

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Intellectual Property GmbH
- Decided: May 13, 2009 after 30 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: 3 generations back to K000969 (2000). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034023: Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1, Microlife Intellectual Property GmbH (2004) Summary page 1.

## Most influential descendants
- K113141: Microlife Dual Mode Thermometer,Model IFR1MJ1 (2012), 1 descendant of its own
- K163256: Dual Mode Infrared Thermometer (2017), 0 descendants of its own

## Indications for use
The Microlife Digital Infrared Ear Thermometer IR1DVI-1 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/K091040
Methodology: https://510kreport.com/methodology