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HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Flui…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223865

by Edwards Lifesciences LLC

Identifiers

510(k) Number
K223865 FDA 510(k)
FDA Product Code
DQK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1425 FDA 510(k)
Regulation Number
870.1425 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The HemoSphere Advanced Monitor is a hemodynamic monitoring platform designed to provide clinical insights through the integration of various sensors and modules. It incorporates the HemoSphere ClearSight Module and the Acumen Assisted Fluid Management software feature to support patient management.

This system is supplied with an Acumen AFM Cable, Acumen IQ fluid meter, Pressure Controller, and Heart Reference Sensor. The device is authorized under FDA 510K clearance number K223865.

Frequently asked questions

What is the purpose of the HemoSphere Advanced Monitor system?

The HemoSphere Advanced Monitor is a hemodynamic monitoring platform designed to provide clinical insights for patient management. It integrates various sensors and modules, including the ClearSight Module and the Acumen Assisted Fluid Management software feature, to assist clinicians in monitoring patient status.

What components are included with this monitoring system?

The system is supplied with the HemoSphere Advanced Monitor, the HemoSphere ClearSight Module, and the Acumen Assisted Fluid Management software feature. Additionally, it includes the necessary hardware components: the Acumen AFM Cable, the Acumen IQ fluid meter, a Pressure Controller, and a Heart Reference Sensor.

What is the regulatory status of this device?

This device is authorized under FDA 510K clearance number K223865. The submission was processed as a traditional 510K and determined to be substantially equivalent to existing devices within the cardiovascular advisory committee category.

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. Sources consulted: HemoSphere | Edwards Lifesciences, HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen ..., HemoSphere™ Monitor - BD

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Edwards Lifesciences LLC
FDA Applicant
Edwards Lifesciences, LLC

Sources (1)

  • FDA 510(k) K223865 24 fields · synced Sep 25, 2026