# K023338: Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,Model-2

- Pathway: 510(k) (Traditional)
- Applicant: Fms, Finapres Medical Systems BV
- Decided: May 9, 2003 after 214 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: 2 generations back to K880572 (1988). 4 ancestors in all.
8 later devices descend from it; 3 cite 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)
- K822055: Cnibp Blood Pressure Measurement Sys, Ohio Medical Products (1982) Summary page 2.
- K880572: Ohmeda 2350 Finapres (R) Blood Pressure Monitor, Ohmeda Medical (1988) Summary page 2.
- K014063: Task Force Monitor 3040, Cnsystems Medizintechnik GmbH (2002)

## Most influential descendants
- K141460: Finapres Nova Noninvasive Hemodynamic Monitor (2015), 4 descendants of its own
- K160967: Finapres Nova Noninvasive Hemodynamic Monitor (2017), 3 descendants of its own
- K173916: Finapres Nova Noninvasive Hemodynamic Monitor (2018), 2 descendants of its own
- K093981: Yrnsortip Oximanometer (2010), 1 descendant of its own
- K223332: Task Force CORE (2023), 0 descendants of its own

## Recalls of this device
- Jul 6, 2012 · Class II · Z-2150-2012: Battery may become hot and leak

## Indications for use
The Portapres Ambulatory Continuous Non-Invasive Blood Pressure Monitor is intended to provide the user with continuous, noninvasive blood pressure and pulse rate monitoring. The Portapres enables 24-hour continuous ambulatory measurements. The PC-based Beatscope software used with the data from the device provides Modelflow-based computation of real-time and beat-to-beat blood pressure as well as hemodynamic parameters from the pressure waveform, including, cardiac output and total peripheral resistance.

Source page: https://510kreport.com/device/K023338
Methodology: https://510kreport.com/methodology