# K091589: Microlife Digital Electronic Thermometer, Model MT16K1

- Pathway: 510(k) (Special)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Jun 10, 2009 after 8 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 K851146 (1985). 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)
- K851146: Digital Thermometer, Micro Idea Instrument Co., Ltd. (1985) Summary page 1.

## Indications for use
The Microlife Digital Electronic Thermometer MT16K1 is used for the intermittent measurement and monitoring of human body temperature, oral, rectal and under the arm. The device is for the adult and pediatric population.

Source page: https://510kreport.com/device/K091589
Methodology: https://510kreport.com/methodology