IntelliVue Patient Monitors MX400, MX450, MX500, MX550
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K251146 FDA 510(k)
- FDA Product Code
- MHX FDA 510(k)
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 MX400, MX450, MX500, and MX550 are physiological patient monitors designed for arrhythmia detection and alarm functionality. These devices continuously monitor vital signs such as ECG, blood pressure, pulse oximetry, and respiratory parameters to assess cardiac and hemodynamic status in clinical settings. They are classified under the FDA’s regulation for arrhythmia detectors and alarms, ensuring compliance with standards for cardiovascular monitoring.
These monitors are intended for use in acute and critical care environments, including hospitals, intensive care units, and emergency departments. Supplied as reusable medical devices, they undergo regulatory authorizations including FDA 510(k) clearance and MDR compliance. Each model varies in functionality and portability, with the MX400 and MX450 designed for bedside or portable use, while the MX500 and MX550 offer expanded capabilities for advanced monitoring. Storage and handling follow standard medical device protocols to maintain sterility and operational integrity.
Frequently asked questions
Are the IntelliVue MX monitors designed for single-use or reusable in clinical settings, and how does this affect their maintenance requirements?
The IntelliVue MX400, MX450, MX500, and MX550 are reusable medical devices, meaning they are intended for repeated use in clinical environments like hospitals and intensive care units. Since they are not single-use, proper cleaning, disinfection, and maintenance protocols must be followed to ensure reliability, sterility, and accurate monitoring. Philips provides guidelines for servicing and calibration to maintain their performance and compliance with regulatory standards.
What types of vital signs can the IntelliVue MX monitors detect, and are they specifically designed for patients with cardiac concerns?
The IntelliVue MX monitors are primarily designed for continuous physiological monitoring, including ECG (electrocardiogram), blood pressure, pulse oximetry, and respiratory parameters. They feature arrhythmia detection and alarm functionality, making them particularly suited for assessing cardiac and hemodynamic status in acute and critical care settings. Their capabilities align with FDA’s classification for arrhythmia detectors and alarms.
How do the MX400, MX450, MX500, and MX550 models differ in terms of functionality and intended use?
The MX400 and MX450 are designed for bedside or portable use, offering essential monitoring features for acute care environments. In contrast, the MX500 and MX550 provide expanded capabilities, including advanced monitoring functions, likely making them better suited for high-acuity settings like intensive care units or emergency departments. While all models share core arrhythmia detection and alarm functionality, their portability and feature sets vary to accommodate different clinical needs.
What regulatory pathways have the IntelliVue MX monitors undergone, and how does this impact their use in hospitals?
The IntelliVue MX monitors have received FDA 510(k) clearance and comply with EU MDR (Medical Device Regulation). This means they meet U.S. and European regulatory standards for physiological patient monitors with arrhythmia detection and alarms, ensuring their safety, performance, and compliance in hospitals. Their classification under FDA’s cardiovascular category further validates their suitability for critical cardiac 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. Sources consulted: IntelliVue Patient monitors MX400, MX450, MX500, MX550 (K251146) — FDA ..., IntelliVue MX400 Portable/bedside patient monitor - Philips, IntelliVue Patient monitors MX400, MX450, MX500, MX550
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K251146 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Boeblingen GmbH
Sources (2)
- FDA 510(k) K251146 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026