# K131829: Intellivue Patient Monitor - Pathway: 510(k) (Special) - Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN - Decided: Aug 16, 2013 after 57 days - Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)) - Device class: 2 - Regulation: 21 CFR 870.1025 - Recalls of this device: none - 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. No later device cites it as a predicate yet. 1 of 230 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. - 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 3. - K091927: Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2009) Summary page 3. - K091395: MP5 Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2009) Summary page 3. - 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 3. - K083228: Philips Intellivue MP5 Patient Monitor, Philips Medizin Systeme Boblingen GmbH (2008) Summary page 3. - 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 3. - K082583: Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2009) Summary page 3. - K081793: Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry System Transceiver, Philips Medizin Systeme Boeblingen GmbH (2008) Summary page 3. - K072070: Philips MP2 and X2 Intellivue Patient Monitors, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2007) Summary page 3. - 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 3. - K063725: MP5 Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2007) Summary page 3. - K063315: Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90, Philips Medizin Systeme Boeblingen GmbH (2006) Summary page 3. - K062392: Philips MP5 Intellivue Patient Monitor, Philips Medizin Systeme Boeblingen GmbH (2006) Summary page 3. ## 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 MP5 and MP5SC 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 and MP5SC when used with the TRx4841A/TRX4851A 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 ECU measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AMI 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 measurement is intended for use with adult and pediatric patients in a hospital environment. The SSC Sepsis Protocol, in the Protocol Watch clinical decision support tool, is intended for use with adult patients only. The integrated Pulmonary Index (121) 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. Source page: https://510kreport.com/device/K131829 Methodology: https://510kreport.com/methodology