# K151681: IntelliVue Patient Monitor - Pathway: 510(k) (Special) - Applicant: Philips Medizin Systeme Boeblingen GmbH - Decided: Jul 17, 2015 after 25 days - Product code: DSI (Detector And Alarm, Arrhythmia) - 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: 35 generations back to K941811 (1994). 232 ancestors in all. 32 later devices descend from it; 1 cites it directly. 1 of 265 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K141015: Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient Monitor MX500, Intellivue Patient, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2014) Summary page 9. - K130849: Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2013) Summary page 9. - K131872: Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2013) Summary page 9. - K122439: Intellivue Patient Monitor, Philips Medizin Systeme Boeblingen GmbH (2012) Summary page 9. - K120366: Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2012) Summary page 9. - K113441: Physiological Monitor, Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2012) Summary page 9. - K113657: Intellivue Patient Monitor, Philips Medizin Systeme Boblingen GmbH (2012) Summary page 9. - K110474: Philips Intellivue TCG10, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2011) Summary page 9. - K110622: Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2011) Summary page 9. - 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 9. - K101449: Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2010) Summary page 9. - 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 9. - K093268: Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2010) Summary page 9. - K091927: Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2009) Summary page 9. - 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 9. - 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 9. - K081793: Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry System Transceiver, Philips Medizin Systeme Boeblingen GmbH (2008) Summary page 9. - K072070: Philips MP2 and X2 Intellivue Patient Monitors, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2007). Our reading of the summary gave K072020, FDA’s number for Restoration Adm System (Howmedica Osteonics Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “IntelliVue Patient Monitors”. - 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 9. - K063315: Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90, Philips Medizin Systeme Boeblingen GmbH (2006) Summary page 9. - K063725: MP5 Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2007) Summary page 9. - K062283: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient Monitors, Philips Medical Systems North America, Inc. (2006) Summary page 9. - K062392: Philips MP5 Intellivue Patient Monitor, Philips Medizin Systeme Boeblingen GmbH (2006) Summary page 9. - K061610: Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH (2006) Summary page 9. - K061052: The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90, Philips Medical Systems North America, Inc. (2006) Summary page 9. - K060541: The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors, Philips Medizin Systeme Boblingen GmbH (2006) Summary page 9. ## Most influential descendants - 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 - K221704: HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) (2022), 6 descendants of its own - K210906: IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4 (2021), 6 descendants of its own - K181314: IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension (2018), 6 descendants of its own ## Recalls of this device - Oct 31, 2025 · Class II · Z-0856-2026: Potential issue where the IntelliVue monitors did not alarm. - Oct 31, 2025 · Class II · Z-0854-2026: Potential issue where the IntelliVue monitors did not alarm. - Oct 31, 2025 · Class II · Z-0853-2026: Potential issue where the IntelliVue monitors did not alarm. - Oct 31, 2025 · Class II · Z-0858-2026: Potential issue where the IntelliVue monitors did not alarm. - Oct 31, 2025 · Class II · Z-0855-2026: Potential issue where the IntelliVue monitors did not alarm. - Oct 31, 2025 · Class II · Z-0857-2026: Potential issue where the IntelliVue monitors did not alarm. - Jan 18, 2023 · Class II · Z-0007-2025: The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. This issue concerns the G7m's sample gas pump which could stop wo - Jun 25, 2020 · Class II · Z-2689-2020: The device may experience an interruption of gas measurement due to a firmware issue, ceasing measurement and display of gas levels and generating one or more technical or INOP alarms. ## 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 MP40/MP50 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 MX500/MX550 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 transcutaneous gas measurement (tcGas) with the M1018A plug-in module 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 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 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. Source page: https://510kreport.com/device/K151681 Methodology: https://510kreport.com/methodology