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IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K161531

by Philips Medizin Systeme Boeblingen GmbH

Identifiers

510(k) Number
K161531 FDA 510(k)
FDA Product Code
MHX FDA 510(k)
Models / Variants
IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2 FDA 510(k)EUDAMED
IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60 FDA 510(k)EUDAMED
IntelliVue Patient Monitors MP70, MP80, MP90 FDA 510(k)EUDAMED
IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600 FDA 510(k)EUDAMED
IntelliVue Patient Monitors MX700, MX800 FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1025 FDA 510(k)
Regulation Number
870.1025 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The IntelliVue Patient Monitors are physiological patient monitors designed for continuous, non-invasive monitoring of vital signs. These devices detect and display multiple parameters, including arrhythmias, to support clinical assessment and patient care in acute and critical care settings. They are classified as Class II medical devices under FDA regulations and are intended for use in cardiovascular monitoring environments.

These monitors are supplied as reusable, non-sterile devices and are intended for use in hospital settings, including intensive care units and emergency departments. They are compatible with MRI environments as specified by their design and labeling. Each model varies in functionality and display capabilities, with some featuring advanced multi-measurement modules. Authorisations include FDA 510K clearance and MDR compliance, ensuring adherence to regulatory standards for patient monitoring devices.

Frequently asked questions

Are these IntelliVue Patient Monitors designed for single-use or can they be reused in a clinical setting?

The IntelliVue Patient Monitors are explicitly supplied as reusable devices, not intended for single-use. They are meant for use in hospital environments like intensive care units and emergency departments, where they undergo routine cleaning and maintenance to ensure ongoing reliability and safety.

What types of vital signs and monitoring capabilities do these devices provide, and where are they primarily used?

These monitors continuously and non-invasively track multiple physiological parameters, including arrhythmias, to support clinical assessment. They are specifically designed for cardiovascular monitoring environments, such as acute and critical care settings, where real-time patient data is critical for decision-making.

Are these monitors compatible with MRI environments, and how does this affect their use in clinical settings?

Yes, the IntelliVue Patient Monitors are designed and labeled to be compatible with MRI environments. This means they can be safely used in hospitals where MRI scans are performed, reducing the need for separate monitoring equipment in those areas.

How do I determine which model of IntelliVue Patient Monitor is best suited for my clinical needs?

The IntelliVue Patient Monitors come in multiple models (e.g., MP2, MP50, MX400, MX800), each with varying functionality and display capabilities. The best choice depends on your specific requirements—such as the number of parameters you need to monitor, advanced features like multi-measurement modules, or the level of detail required for patient assessment. Consulting the manufacturer’s specifications or a clinical specialist can help align the right model with your workflow.

What regulatory pathways have these devices undergone, and what does that mean for their use in healthcare facilities?

The IntelliVue Patient Monitors have received FDA 510(k) clearance and comply with the EU Medical Device Regulation (MDR). This means they meet U.S. and European regulatory standards for safety and performance, ensuring they can be legally used in certified healthcare facilities in both regions. The classification as Class II devices under FDA regulations also indicates they undergo rigorous review for their intended use in cardiovascular monitoring.

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

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medizin Systeme Boeblingen GmbH

Sources (2)

  • FDA 510(k) K161531 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026