# K122121: Pulsioflex Monitoring System with Picco Module

- Pathway: 510(k) (Special)
- Applicant: Pulsion Medical Systems SE
- Decided: Aug 2, 2012 after 16 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
No predicates in its family tree.
4 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K172259: PulsioFlex Monitoring System (2018), 3 descendants of its own
- 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

## Indications for use
The PULSION PulsioFlex Monitoring System with optional PiCCO Module is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVox oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System with PiCCO Module measures oxygen saturation to assess oxygen delivery and consumption in adults and pediatrics. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PulsioFlex Monitoring System measures heart rate, systolic, and diastolic and derives mean arterial and central venous pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for the determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PulsioFlex monitor presents the derived parameters indexed to body surface area.

Source page: https://510kreport.com/device/K122121
Methodology: https://510kreport.com/methodology