# K122439: Intellivue Patient Monitor - Pathway: 510(k) (Special) - Applicant: Philips Medizin Systeme Boeblingen GmbH - Decided: Aug 29, 2012 after 19 days - Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)) - Device class: 2 - Regulation: 21 CFR 870.1025 - Recalls of this device: 4 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 32 generations back to K941811 (1994). 228 ancestors in all. 41 later devices descend from it; 7 cite it directly. 1 of 270 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - 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. - K110474: Philips Intellivue TCG10, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2011) 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. - K101449: Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2010) Summary page 2. - K100939: Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 and MP90, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2010) Summary page 2. - K093268: Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2010) Summary page 2. - K091927: Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2009) 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. - K081793: Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry System Transceiver, Philips Medizin Systeme Boeblingen GmbH (2008) Summary page 2. - K072070: Philips MP2 and X2 Intellivue Patient Monitors, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2007) 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. - K063725: MP5 Intellivue Patient Monitor, 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. - K062283: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient Monitors, Philips Medical Systems North America, Inc. (2006) Summary page 2. - K062392: Philips MP5 Intellivue Patient Monitor, Philips Medizin Systeme Boeblingen GmbH (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. - 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. - K060541: The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors, Philips Medizin Systeme Boblingen 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. - K053522: Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00, Philips Medizin Systeme Boeblingen GmbH (2006) 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. - K051106: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, 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. - K040304: Philips Intellivue Patient Monitor, Models MP40 & MP50, Philips Medizin Systeme Boeblingen GmbH (2004) Summary page 2. - K033513: Easi Ecg Algorithm, Philips Medical Systems (2004) Summary page 2. - K033444: Philips Medical Systems, M3012A- Hemodynamic Extension to the Multi-Measurement Server, Philips Medical Systems (2003) Summary page 2. - K032858: The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O., Philips Medizin Systeme Boblingen GmbH (2003) Summary page 2. - K031481: The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20, Philips Medizin Systeme Boblingen GmbH (2003) Summary page 2. - K030038: Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185 Opt C41 Wireless Bedside Adaptr, Philips Medical Systems, Inc. (2003) Summary page 2. - K023871: M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient Monitor with Portal Technology, Philips Medical Systems (2002) Summary page 2. - K021778: Philips Component Compact Monitor, Release a.04, Model #M1275B, Philips Medical Systems (2002) Summary page 2. ## Most influential descendants - K131872: Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550 (2013), 37 descendants of its own - K130849: Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450 (2013), 37 descendants of its own - 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 ## Recalls of this device - Oct 31, 2025 · Class II · Z-0852-2026: Potential issue where the IntelliVue monitors did not alarm. - Oct 31, 2025 · Class II · Z-0851-2026: Potential issue where the IntelliVue monitors did not alarm. - May 4, 2017 · Class II · Z-2175-2017: Manufacturing defect may cause localized heating, which may result in localized skin burn. - Oct 3, 2014 · Class II · Z-0104-2015: Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped ## Indications for use The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The monitor is intended to be used for monitoring and recording of, and to generate alarms, for, multiple physiological parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained healthcare professionals in a hospital environment. The monitor is also intended for use during patient transport inside and outside of the hospital environment. The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is 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 EC 11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. 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 MP5, MP5SC and MP5T monitors are also intended for use during patient transport inside the hospital environment; only the MP5 monitor is for use during patient transport outside of the hospital environment. The MP5, MP5SC and MP5T when used with the TRx4S4lA/TRx4B5lA IntelliVue Telemetry System Transceiver or with the IntelliVue Cableless Measurement Devices, are intended for use in a hospital environment and during patient transport inside the hospital environment. 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 EC 11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. The Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment. 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 IPI 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. 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 MP2O/MP3O/MP4O/MP5O 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 EC 11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. 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. The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only. BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation. 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 IPI is an adjunct to and not intended to replace vital sign monitoring. The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients. 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 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 EC 11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only. BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation. The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only. 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. The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring. The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients. The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The monitor is intended to be used for monitoring and recording of, and to generate alarms, for, multiple physiological parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained healthcare professionals in a hospital environment. The monitor is also intended for use during patient transport inside and outside of the hospital environment. The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is 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 EC 11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring. Source page: https://510kreport.com/device/K122439 Methodology: https://510kreport.com/methodology