# K222979: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Intellectual Property GmbH
- Decided: May 19, 2023 after 233 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). 22 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K232621: Blood pressure monitor (2023), 3 descendants of its own
- K253425: Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P) (2026), 0 descendants of its own
- K252685: Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) (2026), 0 descendants of its own
- K241351: Blood Pressure Monitor (TMB-2092-G) (2024), 0 descendants of its own
- K231116: Multi-parameter detector (2024), 0 descendants of its own

## Indications for use
The Upper Arm Blood Pressure Monitor, Model BP3KV1-5W 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 22 to 52cm. The device is suitable for use by adults, including adults with conditions of diabetes, pregnancy, or pre-eclampsia. 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/K222979
Methodology: https://510kreport.com/methodology