# K132528: E-Picco Continuous Cardiac Output Module and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare Finland Oy
- Decided: Jan 16, 2014 after 157 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: 1 generation back to K060898 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060898: Pulsion Picco Plus, Model 8100, Pulsion Medical Systems AG (2006) Summary page 1.

## Indications for use
Indications for use E-PiCCO Continuous Cardiac Output Module: The E-PiCCO 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 E-PiCCO measures 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 compatible patient monitor presents the derived parameters indexed to body surface area. The E-PiCCO is intended for hospitalized patients. The E-PiCCO and accessories are for use by qualified medical personnel only. The E-PiCCO patient module is intended for use on one patient at a time. Cardiac output measurement with E-PiCCO is intended for patients weighing over 2 kg (4.4 lb) and therefore it is not available for smaller patients. E-PiCCO indexed values are available for patients weighing over 15 kg (33 lb) only. Indications for use PiCCO Continuous Cardiac Output Cable (M 1154585): The reusable, continuous cardiac output adapter cables are intended to be used for connecting a continuous cardiac output catheter to GE Medical Systems Information Technologies monitoring equipment requiring a rectangular 11I-pin connector cable. These accessories are indicated for use by qualified medical personnel only. Indications for use PiCCO Iniectate Sensor Cable (Ml 182448): The reusable PiCCO Injectate Sensor Cable (Ml 182448) is intended to be used for connecting the PiCCO Injectate Sensor Housing* (PV4046) to PiCCO Continuous Cardiac Output Cable (MI 154585) of GE Healthcare monitoring equipment. These accessories are indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K132528
Methodology: https://510kreport.com/methodology