# K192169: PulsioFlex Monitoring System with ProAQT Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Pulsion Medical Systems SE
- Decided: Apr 30, 2020 after 265 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K122121 (2012). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172259: PulsioFlex Monitoring System, Pulsion Medical Systems SE (2018) Summary page 4.

## Indications for use
The PulsioFlex Monitoring System is a diagnostic aid for the measurement and monitoring of blood pressure, cardiopulmonary, circulatory and organ function variables. The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient’s biometric data are entered, the PulsioFlex Monitor presents the derived parameters indexed. - With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters. - With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption. - With the ProAQT Sensor, the PulsioFlex Monitoring System uses arterial pulse contour analysis for continuous hemodynamic monitoring. The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units.

Source page: https://510kreport.com/device/K192169
Methodology: https://510kreport.com/methodology