# K033817: Microlife Digital Infrared Ear Thermometer, Models IR1DA1-2, IR1DE1-2

- Pathway: 510(k) (Special)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Jan 8, 2004 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: 2 generations back to K000969 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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 4.

## Indications for use
The device is an digital infrared Ear 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/K033817
Methodology: https://510kreport.com/methodology