# K130849: Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450 - Pathway: 510(k) (Special) - Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN - Decided: Jun 14, 2013 after 80 days - Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)) - Device class: 2 - Regulation: 21 CFR 870.1025 - Recalls of this device: 8 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 33 generations back to K941811 (1994). 229 ancestors in all. 37 later devices descend from it; 3 cite it directly. 1 of 267 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K122439: Intellivue Patient Monitor, Philips Medizin Systeme Boeblingen GmbH (2012) Summary page 2. - K120366: Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2012) Summary page 2. - K113657: Intellivue Patient Monitor, Philips Medizin Systeme Boblingen GmbH (2012) Summary page 2. - K113441: Physiological Monitor, Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2012) Summary page 2. - K110622: Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2011) Summary page 2. - K102562: Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800, Philips Medizin Systeme Boblingen GmbH (2010) Summary page 2. - K093268: Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2010) Summary page 2. - K083517: Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2009) Summary page 2. - K082633: Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2008) Summary page 2. - K071426: MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient Monitors, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2007) Summary page 2. - K063315: Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90, Philips Medizin Systeme Boeblingen GmbH (2006) Summary page 2. - K062392: Philips MP5 Intellivue Patient Monitor, Philips Medizin Systeme Boeblingen GmbH (2006) Summary page 2. - K062283: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient Monitors, Philips Medical Systems North America, Inc. (2006) Summary page 2. - K061610: Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH (2006) Summary page 2. - K060221: The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH (2006) Summary page 2. - K060541: The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors, Philips Medizin Systeme Boblingen GmbH (2006) Summary page 2. - K061052: The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90, Philips Medical Systems North America, Inc. (2006) Summary page 2. - K052961: The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors, with 802.11 Wireless Lan, Philips Medical Systems (2005) Summary page 2. - K052801: Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90, Philips Medizin Systeme Boeblingen GmbH (2005) Summary page 2. - K050762: Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90, Philips Medizin Systeme Boeblingen GmbH (2005) Summary page 2. - K050141: The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH (2005) Summary page 2. - K042845: The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors, Philips Medizin Systeme Boblingen GmbH (2004) Summary page 2. - K041235: Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH (2004) Summary page 2. ## Most influential descendants - K141015: Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient Monitor MX500, Intellivue Patient (2014), 36 descendants of its own - K150975: Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors (2015), 34 descendants of its own - K151681: IntelliVue Patient Monitor (2015), 32 descendants of its own - K161531: IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800 (2016), 31 descendants of its own - K171801: IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable (2017), 8 descendants of its own ## Recalls of this device - Oct 31, 2025 · Class II · Z-0862-2026: Potential issue where the IntelliVue monitors did not alarm. - Oct 31, 2025 · Class II · Z-0863-2026: Potential issue where the IntelliVue monitors did not alarm. - Aug 30, 2024 · Class II · Z-3249-2024: During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of elect - Jun 28, 2024 · Class II · Z-2510-2024: Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version - Jun 28, 2024 · Class II · Z-2508-2024: Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version - Jun 28, 2024 · Class II · Z-2509-2024: Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version - Jun 28, 2024 · Class II · Z-2511-2024: Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version - Jun 14, 2023 · Class II · Z-0020-2025: Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in ## Indications for use The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment. The monitors are additionally intended for use in transport situations within hospital environments, The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only. The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only. The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPl is an adjunct to and not intended to replace vital sign monitoring, The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients. Source page: https://510kreport.com/device/K130849 Methodology: https://510kreport.com/methodology