# K183469: Microlife Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Mar 12, 2019 after 88 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: 8 generations back to K903134 (1991). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172880: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Microlife Intellectual Property GmbH (2018) Summary page 4.

## Most influential descendants
- K190818: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2019), 0 descendants of its own

## Indications for use
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GX1-5X (BP A3 PC) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual of 12 years and older, with arm circumference sizes ranging from 22 -52 cm by using a non-invasive oscillometric technique in an inflatable cuff 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 your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable with PC. The blood pressure monitor is a fully automatic digital blood pressure measuring device for use by adults(also applicable to the diabetic patients) on the upper arm at home or in your doctor’s/nurse’s office.

Source page: https://510kreport.com/device/K183469
Methodology: https://510kreport.com/methodology