# K230075: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Jun 28, 2023 after 169 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: 10 generations back to K903134 (1991). 24 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172498: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y, Microlife Intellectual Property GmbH (2017) Summary page 4.
- K153450: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Microlife Intellectual Property GmbH (2015) Summary page 4.

## Most influential descendants
- K251120: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) (2025), 1 descendant of its own
- K253982: Korotkoff sound blood pressure monitor (2026), 0 descendants of its own

## Indications for use
The Upper Arm Blood Pressure Monitor, Model BP3KV1-5K is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm for a circumference range from 17 to 52cm. 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 via Bluetooth or with a personal computer (PC) via USB. The measurement data can be transferred to a smart phone running the Microlife Connected Health+ mobile software (App) or a PC running the Microlife BP Analyzer+ (BPA+) software.

Source page: https://510kreport.com/device/K230075
Methodology: https://510kreport.com/methodology