# K060898: Pulsion Picco Plus, Model 8100

- Pathway: 510(k) (Traditional)
- Applicant: Pulsion Medical Systems AG
- Decided: Jul 25, 2006 after 113 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K140017: Transonic HCM 102 System (2014), 0 descendants of its own
- K132528: E-Picco Continuous Cardiac Output Module and Accessories (2014), 0 descendants of its own
- K073113: Infinity Picco Pod, Model MS16734 (2008), 0 descendants of its own

## Indications for use
The PULSION PiCCO Plus is intended for determination and monitoring of cardiopulmonary and circulatory variables. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PiCCO Plus measures heart rate, systolic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PiCCO Plus presents the derived parameters indexed to body surface area.

Source page: https://510kreport.com/device/K060898
Methodology: https://510kreport.com/methodology