# K190818: Microlife Upper Arm Automatic Digital Blood Pressure Monitor

- Pathway: 510(k) (Special)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Jul 10, 2019 after 100 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K903134 (1991). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183469: Microlife Digital Blood Pressure Monitor, Microlife Intellectual Property GmbH (2019) Summary page 4.
- K153077: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Microlife Intellectual Property GmbH (2016) Summary page 4.

## Indications for use
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GY1-2N is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual with arm circumference sizes ranging from 22 -42 cm by using a non-invasive oscillometric technique in which an inflatable cuff is being wrapped around the upper arm. The device is also validated for all adult diabetic users. The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected. The device can be used in connection with a smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth. The blood pressure monitor is a fully automatic digital blood pressure measuring device for use by adults (also applicable for diabetic patients) on the upper arm at home or in your doctor's/nurse's office.

Source page: https://510kreport.com/device/K190818
Methodology: https://510kreport.com/methodology