# K072735: Pulsion Picco-2, Model 8500

- Pathway: 510(k) (Special)
- Applicant: Pulsion Medical Systems AG
- Decided: Oct 18, 2007 after 21 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.
71 later devices descend from it; 4 cite it directly.
1 of 72 devices in its family (counting itself) has 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
- K100709: EV1000 Platform Model: EV1000A, EV1000DB, EV1000M (2010), 55 descendants of its own
- K110597: EV1000 Clinical Platform (2011), 54 descendants of its own
- K140312: EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM System (2014), 52 descendants of its own
- K131892: EV1000 Clinical Platform (2014), 52 descendants of its own
- K160552: EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform (2016), 51 descendants of its own

## Indications for use
The PULSION PiCCO-2 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-2 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-2 presents the derived parameters indexed to body surface area.

Source page: https://510kreport.com/device/K072735
Methodology: https://510kreport.com/methodology