HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry C…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213682 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 multi-functional hemodynamic monitoring system designed for critical care environments. It integrates pressure, flow, and tissue oximetry capabilities, enabling comprehensive patient assessment through compatible catheters, sensors, and cuffs such as Swan-Ganz catheters, Acumen IQ sensors, and ClearSight finger cuffs.
This system is used in intensive care units and operating rooms for real-time hemodynamic monitoring, including cardiac output, fluid management, and tissue oxygenation. Supplied as a modular platform with single-use or reusable components depending on the accessory, it operates in non-MRI environments. Authorized under FDA 510(k) clearance (K213682), it adheres to traditional review standards and is intended for use with Edwards-compatible devices.
Frequently asked questions
What types of clinical environments is the HemoSphere Advanced Monitor intended for, and what specific monitoring capabilities does it provide?
The HemoSphere Advanced Monitor is designed for critical care settings like intensive care units (ICUs) and operating rooms. It integrates pressure, flow, and tissue oximetry capabilities to enable real-time monitoring of hemodynamic parameters such as cardiac output, fluid management, and tissue oxygenation. This modular system works with compatible catheters (e.g., Swan-Ganz), sensors (e.g., Acumen IQ), and cuffs (e.g., ClearSight finger cuffs) to provide comprehensive patient assessment.
How is the HemoSphere Advanced Monitor supplied, and are the components single-use or reusable?
The HemoSphere Advanced Monitor is supplied as a modular platform, where individual components like cables (e.g., HemoSphere Oximetry Cable, HemoSphere Pressure Cable) and modules (e.g., Swan-Ganz Module, ClearSight Module) can vary in disposability. Some accessories, such as catheters or sensors, are single-use, while others may be reusable depending on the specific component. Always refer to the manufacturer’s instructions for each accessory to confirm its intended use and reusability.
Does the HemoSphere Advanced Monitor include features for predicting patient complications, and if so, what are they?
Yes, the system includes specialized features like the Acumen Hypotension Prediction Index (HPI) and Acumen Assisted Fluid Management. These features analyze hemodynamic data in real time to predict potential hypotension events and assist clinicians in optimizing fluid management, helping to prevent complications like shock or organ hypoperfusion in critically ill patients.
What regulatory pathway was followed for FDA clearance of the HemoSphere Advanced Monitor, and which advisory committee was involved?
The HemoSphere Advanced Monitor received FDA clearance through the 510(k) pathway (K213682) under traditional review standards. The submission was reviewed by the Cardiovascular (CV) Advisory Committee, which evaluates devices related to cardiovascular monitoring and therapy. The clearance confirms the device’s substantial equivalence to a predicate device already on the market.
Can the HemoSphere Advanced Monitor be used in an MRI environment, and what are its primary limitations?
The HemoSphere Advanced Monitor is explicitly designed for use in non-MRI environments, meaning it should not be used in areas with magnetic resonance imaging equipment. Its primary limitations are tied to its intended clinical setting—it requires compatible Edwards-compatible catheters, sensors, and accessories for full functionality, and its modular design means performance depends on the specific components being used.
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™ Monitor - BD, HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere ..., PDF HemoSphere Monitor - edwards.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213682 | Class II | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA 510(k) K213682 24 fields · synced Oct 6, 2026