# K131913: Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T, MP5SC - Pathway: 510(k) (Abbreviated) - Applicant: Philips Medizin Systeme Boeblingen GmbH - Decided: Nov 26, 2013 after 153 days - Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency) - Device class: 2 - Regulation: 21 CFR 870.2910 - Recalls of this device: 1 (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). 268 ancestors in all. No later device cites it as a predicate yet. 2 of 269 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K101600: Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue Patient Monitors MP5, MP2, X2 Model, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2010) Summary page 3. - K111905: Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2011) Summary page 3. - K122223: New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO, Philips Medizin Systeme Boeblingen GmbH (2013) Summary page 3. - K122439: Intellivue Patient Monitor, Philips Medizin Systeme Boeblingen GmbH (2012) Summary page 3. - K120366: Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2012) Summary page 3. - K113441: Physiological Monitor, Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2012) Summary page 3. - K113657: Intellivue Patient Monitor, Philips Medizin Systeme Boblingen GmbH (2012) Summary page 3. - K110622: Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2011) Summary page 3. - 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 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. - 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. - 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. - K052707: M3046B Compact Portable Patient Monitors, Philips Medical Systems (2005) Summary page 3. - K091395: MP5 Intellivue Patient Monitor, 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. - K081793: Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry System Transceiver, Philips Medizin Systeme Boeblingen GmbH (2008) Summary page 3. - K063725: MP5 Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2007) Summary page 3. - K062392: Philips MP5 Intellivue Patient Monitor, Philips Medizin Systeme Boeblingen GmbH (2006) Summary page 3. ## Recalls of this device - 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 IntelliVue CL SpO2 Pod: The IntelliVue CL SPO 2 Pod is indicated for use by health care professionals whenever there is a need for acquisition or monitoring of physiological patient parameters SpO2 and pulse rate wirelessly. The intended use of the IntelliVue CL SpO2 Pod when used together with a patient monitor or with a telemetry system transceiver is for monitoring, and recording of. and to generate alarms for, arterial oxygen saturation and pulse rate of adult and pediatric patients. The IntelliVue CL SP0 2 Pod is also intended for local attended monitoring of. and to generate alarms for, arterial oxygen saturation and pulse rate of adult and pediatric patients. The IntelliVue CL Sp 0 2 Pod is also intended for acquisition of arterial oxygen saturation and pulse rate data of adult and pediatric patients for a clinical information management system. The IntelliVue CL SPO2 Pod is intended for use by health care professionals inside hospitals. It is not intended for home use. It is not a therapeutic device. Local attended monitoring refers to situations where clinical staff is close to the patient such that acoustic alarming of the IntelliVue CL SPO2 Pod will be noticed. Example: In-hospital transport of a patient by hospital staff to a procedure room. IntelliVue CL NBP Pod: The IntelliVue CL NBP Pod is indicated for use by health care professionals whenever there is a need for acquisition or monitoring of physiological patient parameters non-invasive blood pressure and pulse rate wirelessly. The intended use of the IntelliVue CL NBP Pod when used together with a patient monitor or with a telemietry system transceiver is for monitoring and recording of, and to generate alarms for, systolic, diastolic, and mean pressure, and to measure pulse rate of adult and pediatric patients. The IntelliVue CL NBP Pod is also intended for local attended monitoring of. and to generate alarms for, systolic, diastolic, and mean pressure, and to measure pulse rate of adult and pediatric patients. The IntelliVue CL NBP Pod is also intended for acquisition of systolic, diastolic, and mean pressure and pulse rate data of adult and pediatric patients for a clinical information management system. The IntelliVue CL NBP Pod is intended for use by health care professionals inside hospitals. It is not intended for home use. It is not a therapeutic device. Local attended monitoring refers to situations where clinical staff is close to the patient such that acoustic alarming of the IntelliVue CL NBP Pod will be noticed. Example: In-hospital transport of a patient by hospital staff to a procedure room. IntelliVue Patient Monitors MP5, MP5T, and MP5SC: 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 MI'S. MPSSC and MP5T monitors are also intended for use during patient transport inside the hospital environment: only the MI'S monitor is for use during patient transport outside of the hospital environment. The MI'S, MPSSC and MPST when used with the TP-x484 1A/TRx4851IA 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 AAMIECI 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 Protocol Watch clinical decision support tool, is intended for use with adult patients only. The Integrated Pulmonary Index (MP)is intended for use with adult and pediatric (I to 12 years) patients only. Thle 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/K131913 Methodology: https://510kreport.com/methodology