IntelliVue Patient Monitors MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90

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

Full name

MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient Monitors

510(k) Number

K071426 ↗

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 clinical purposes do these IntelliVue patient monitors serve?

  These monitors are designed for continuous physiological monitoring of patients in clinical settings, with specific functionality for arrhythmia detection and alarms. The MP2, X2, MP5, MP20, MP30, MP40, and MP50 models are additionally intended for use during patient transport within hospital environments, while the MP5 model is also cleared for transport outside of hospital settings.

• How are the monitors supplied and who is the manufacturer?

  The monitors are supplied by Philips Medizinsysteme Boeblingen GmbH, located in Boeblingen, Germany. The company is listed as the applicant and manufacturer for this device family, with the specific address at Hewlett-Packard St. 2, D 71034.

• Are these monitors single-use or reusable, and what is their sterilization status?

  The device data does not specify whether these monitors are single-use or reusable, nor does it provide information about sterilization methods. As physiological monitoring systems intended for continuous use in clinical settings, they are typically reusable medical devices, but the exact reprocessing instructions would need to be confirmed from the manufacturer's labeling.

• What models are included in this monitor family and are there different capabilities?

  The family includes MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 models. The MP2 through MP50 models are intended for transport use within hospitals, with the MP5 also cleared for external hospital transport. Configuration variants mentioned include MP5SC, MP5T, and the X2 Multi-Measurement Module when used as a standalone monitor. Software version H.0 with software H.0x.xx applies across these configurations.

• What regulatory pathway was used for clearance and how should this be documented?

  These monitors were cleared through the FDA 510(k) premarket notification pathway under product code MHX and regulation number 870.1025. The clearance was granted as a Special type with a Substantially Equivalent decision, reviewed by the Cardiovascular advisory committee. The specific 510(k) number is K071426, with a decision date of June 13, 2007. The devices are classified as Class II and have multiple registration and FEI numbers on file.