# K163256: Dual Mode Infrared Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Intelliworks, LLC
- Decided: Apr 6, 2017 after 136 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: 5 generations back to K000969 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113141: Microlife Dual Mode Thermometer,Model IFR1MJ1, Microlife Intellectual Property GmbH (2012) Summary page 4.
- K033077: Easytem Duo, Forehead/Ear Thermometer, Model BT-021, Metatech Co., Ltd. (2004) Summary page 4.

## Indications for use
The Dual Mode Infrared Thermometer (Model DM-IR200) is intended for the intermittent measurement and monitoring of human body temperatures. It is for non-professional use by consumers at home. The ear canal mode is indicated for use by people above one year old and the skin/forehead mode is indicated for use by people of all ages.

Source page: https://510kreport.com/device/K163256
Methodology: https://510kreport.com/methodology