IntelliVue MP2 and X2 Patient Monitors

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Philips MP2 and X2 Intellivue Patient Monitors

510(k) Number

K072070 ↗

FDA Product Code

MHX

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Intellivue Patient Monitor

  Class II

  FDA 510(k) K110622 Active Cleared 31 Mar 2011

• Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50

  Class II

  FDA 510(k) K111083 Active Cleared 17 Aug 2011

• Intellivue Cl SP02 Pod Model 865215, Intellivue Cl Nbp Pod Model 865216, Intellivue Patient Monitors MP5, MP2, X2 Model

  Class II

  FDA 510(k) K101600 Active Cleared 31 Aug 2010

• Intellivue Guardian Software Model 866009, Intellivue Cl SP02 Pod Model 865215, Intellivue Cl Nbp Pod Model 865216

  Class II

  FDA 510(k) K111905 Active Cleared 4 Oct 2011

• Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 and MP90

  Class II

  FDA 510(k) K100939 Active Cleared 30 Apr 2010

• Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90

  Class II

  FDA 510(k) K083517 Active Cleared 16 Jan 2009

See all devices from Philips Medizinsysteme Boeblingen GmbH, Cardiac AN →

• What patient populations are the Philips IntelliVue MP2 and X2 monitors designed for?

  The Philips IntelliVue MP2 and X2 Patient Monitors are specifically designed for continuous monitoring of adults, pediatrics, and neonates in clinical settings. Their multi-parameter capabilities, including arrhythmia detection and alarm systems, make them suitable for diverse patient populations requiring real-time vital sign assessment, such as in intensive care units, operating rooms, or during patient transport.

• Are the Philips IntelliVue MP2 and X2 monitors reusable or single-use?

  The Philips IntelliVue MP2 and X2 Patient Monitors are reusable medical devices. They are engineered for repeated use in clinical environments where rigorous cleaning, disinfection, and maintenance protocols are followed to ensure patient safety and device reliability. Reusability aligns with their design for high-dependency areas like hospitals, where continuous monitoring demands durable, long-term functionality.

• What types of alarms and monitoring features do these monitors include?

  These monitors feature arrhythmia detection and comprehensive alarm systems to alert caregivers to critical changes in patient status. Beyond standard vital signs like heart rate, blood pressure, and oxygen saturation, they provide real-time monitoring and alerts tailored for clinical decision-making, ensuring timely intervention for abnormalities. The alarm capabilities are integrated to support continuous oversight in dynamic environments like patient transport or critical care.

• Can the Philips IntelliVue MP2 and X2 monitors be used during MRI procedures?

  No, the Philips IntelliVue MP2 and X2 Patient Monitors are not classified as MRI-safe or MRI-conditional. Their design and materials are not compatible with magnetic resonance imaging environments, which require specialized shielding and electromagnetic compatibility to avoid interference or patient harm. Clinicians must use alternative monitoring solutions when patients require concurrent MRI procedures.

• What regulatory pathway was followed for FDA clearance of these monitors?

  The Philips IntelliVue MP2 and X2 Patient Monitors received FDA 510(k) clearance under the Special 510(k) Review Program, with a decision classification of *Substantially Equivalent* (SESE). This pathway was used for their cardiovascular applications, as indicated by the advisory committee designation (CV). The clearance reflects compliance with U.S. regulatory requirements for Class II medical devices, ensuring their safety and effectiveness for continuous patient monitoring in designated clinical settings.