# K183663: Microlife Digital Infrared Ear Thermometer

- Pathway: 510(k) (Special)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Jul 16, 2019 after 201 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 K003308 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003308: Microlife Digital Infrared Ear Thermometer, IR1DAI, IR1DB1, IR1DD1, Microlife Corp. (2000) Summary page 4.

## Indications for use
The Microlife Digital Infrared Ear Thermometer, Model IRIDN1 (IR210) 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/K183663
Methodology: https://510kreport.com/methodology