# K161728: Microlife Digital Infrared Forehead Thermometer, Model  FR1MN1-1

- Pathway: 510(k) (Traditional)
- Applicant: Microfile Intellectual Property GmbH
- Decided: Dec 5, 2016 after 166 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.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033820: Microlife Digital Infrared Forehead Thermometer, Model FR1DM1, Microlife Intellectual Property GmbH (2004) Summary page 4.

## Most influential descendants
- K172874: Infrared Thermometer (2018), 0 descendants of its own

## Indications for use
The Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 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/K161728
Methodology: https://510kreport.com/methodology