# K172259: PulsioFlex Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Pulsion Medical Systems SE
- Decided: Jan 18, 2018 after 175 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- 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: 1 generation back to K122121 (2012). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122121: Pulsioflex Monitoring System with Picco Module, Pulsion Medical Systems SE (2012) Summary page 4.

## Most influential descendants
- K183521: CNAP Monitor (2019), 1 descendant of its own
- K223332: Task Force CORE (2023), 0 descendants of its own
- K192169: PulsioFlex Monitoring System with ProAQT Sensor (2020), 0 descendants of its own

## Recalls of this device
- Jun 5, 2019 · Class II · Z-2077-2019: The monitor displays an error message . The error message states "internal error restart or service".

## 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. 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/K172259
Methodology: https://510kreport.com/methodology