# K033820: Microlife Digital Infrared Forehead Thermometer, Model FR1DM1

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Feb 23, 2004 after 76 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.
23 later devices descend from it; 3 cite it directly.
0 of 27 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
- 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
- K150869: Checkme Pro Health Monitor (2015), 5 descendants of its own
- K191088: Checkme O2 Pulse Oximeter (2019), 2 descendants of its own
- K211776: Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) (2022), 1 descendant of its own

## Indications for use
The Microlife Digital Infrared Forehead Thermometer, Model FRI DM1 is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.

Source page: https://510kreport.com/device/K033820
Methodology: https://510kreport.com/methodology