E-PICCO Continuous Cardiac Output Module and Accessories
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132528 FDA 510(k)
- FDA Product Code
- DXG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1435 FDA 510(k)
- Regulation Number
- 870.1435 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The E-PICCO Continuous Cardiac Output Module and Accessories is a pre-programmed, single-function diagnostic computer system designed for continuous monitoring of cardiac output and related hemodynamic parameters. It utilises the transpulmonary thermodilution technique to provide real-time assessment of cardiac function, intravascular volume status, and tissue perfusion, supporting critical care and intraoperative management in cardiovascular patients.
This device is supplied as a modular system, including the main monitoring unit and associated accessories for calibration and patient interfacing. It is intended for single-use in clinical settings such as intensive care units, operating rooms, and emergency departments, where continuous hemodynamic monitoring is required. The system is not MRI-safe and must be used in non-MRI environments. Authorisations include FDA 510K clearance under the classification of Class II medical devices, as well as compliance with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR).
Frequently asked questions
What is the E-PICCO Continuous Cardiac Output Module used for?
The E-PICCO Continuous Cardiac Output Module is designed for continuous monitoring of cardiac output and related hemodynamic parameters using the transpulmonary thermodilution technique. It provides real-time assessment of cardiac function, intravascular volume status, and tissue perfusion, supporting critical care and intraoperative management in cardiovascular patients.
How is the E-PICCO system supplied?
The E-PICCO system is supplied as a modular system, including the main monitoring unit and associated accessories for calibration and patient interfacing. It is intended for single-use in clinical settings such as intensive care units, operating rooms, and emergency departments.
Is the E-PICCO system MRI-safe?
No, the E-PICCO system is not MRI-safe and must be used in non-MRI environments. It is designed for use in standard clinical settings where continuous hemodynamic monitoring is required.
What regulatory approvals does the E-PICCO system have?
The E-PICCO system has FDA 510K clearance under the classification of Class II medical devices, as well as compliance with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). These authorizations indicate it meets regulatory requirements for safety and performance.
In what clinical settings is the E-PICCO system typically used?
The E-PICCO system is typically used in clinical settings such as intensive care units, operating rooms, and emergency departments where continuous hemodynamic monitoring is required for cardiovascular patients.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K132528 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
Sources (2)
- FDA 510(k) K132528 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026