# K152770: ProBP 2400 Digital Blood Pressure Device

- Pathway: 510(k) (Special)
- Applicant: Microlife Intellectual Property GmbH
- Decided: Oct 21, 2015 after 26 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K903134 (1991). 30 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143341: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Microlife Intellectual Property GmbH (2015) Summary page 4.

## Most influential descendants
- K200297: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2020), 2 descendants of its own
- K222153: Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) (2023), 0 descendants of its own
- K202729: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2021), 0 descendants of its own

## Recalls of this device
- Feb 27, 2017 · Class II · Z-1777-2017: A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 may potentially cause an over-voltage battery charging condition when the device is connected to the exte

## Indications for use
The ProBP 2400 is a non-invasive digital blood pressure device using oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate and mean arterial pressure (MAP) for use in pediatric and adult populations with arm cuff circumference sizes ranging from 14 - 52 cm. 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 accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia.

Source page: https://510kreport.com/device/K152770
Methodology: https://510kreport.com/methodology