# K101600: Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue Patient Monitors MP5, MP2, X2 Model - Pathway: 510(k) (Abbreviated) - Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN - Decided: Aug 31, 2010 after 84 days - Product code: DQA (Oximeter) - Device class: 2 - Regulation: 21 CFR 870.2700 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 29 generations back to K941811 (1994). 229 ancestors in all. 37 later devices descend from it; 2 cite it directly. 2 of 267 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K043517: Transmitter, ZS-940PA Series, Nihon Kohden America, Inc. (2005) 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. - K041741: M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry System II Including M4841A Patien, Philips Medical Systems, Inc. (2004) Summary page 2. - K040357: M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry Monitoring System II, Philips Medical Systems, Inc. (2004) Summary page 2. - K001333: Agilent Component Monitoring System, Agilent Multi-Measurement Server and Compact Portable Patient Monitor, Agilent Noni, Agilent Technologies Deutschland GmbH (2000) Summary page 2. - K013427: Modification to:Philips M3000A/M3046A Compact Portable Patient Monitor, Models Philips M3000A/M3046A, Philips Medical Systems, Inc. (2001) Summary page 2. - K020531: Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release a.02, Model M1275B, Philips Medical Systems (2002) Summary page 2. - K030973: Picosat II SPO2 Pulse Oximetry Module, Philips Medical Systems (2003) Summary page 2. - K033715: Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement Server, Philips Medical Systems, Inc. (2004) Summary page 2. - K062268: Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03, Philips Medical Systems North America Co. (2006) Summary page 2. - K090360: Philips M3001A Multi Measurement Server, Philips Medizin Systeme Boblingen GmbH (2009) Summary page 2. - K031187: Heartstart MRX, Model M3535A, Philips Medical Systems (2003) Summary page 2. - K071885: Antimicrobial and Single-Patient Cuffs, Philips Medical Systems (2007) Summary page 2. - K941811: HP M1175A, M1176A, Component Monitoring System, Hewlett-Packard Co. (1994) Summary page 2. - K925910: Hewlett-Packard Model M1018A TCPO2/TOPCO2 Module, Hewlett-Packard Co. (1993) Summary page 2. - K923682: Model M1032A Vuelink Interface Plug-in Module, Hewlett-Packard Co. (1992) Summary page 2. - K923343: Hewlett-Packard Model M1020A Pulse Oximeter, Hewlett-Packard Co. (1993) Summary page 2. - K922058: Models M1175A and M1176A Component Monitoring Syst, Hewlett-Packard Co. (1992) Summary page 2. - K910490: Modified Monitoring System Models M1175A & M1176A, Hewlett-Packard Co. (1991) Summary page 2. - K903771: HP Model M1008B, Noninvasive Blood Pressure Module, Hewlett-Packard Co. (1991) Summary page 2. - K903523: HP Model M1020A, Arterial Oxygen Sat/Pleth Module, Hewlett-Packard Co. (1990) Summary page 2. - K900032: Model M1175A/M1176A with ST Segment Monitoring, Hewlett-Packard Co. (1990) Summary page 2. - K896030: Hewlett-Packard Model M1016A CO2 & M1017A FI02, Hewlett-Packard Co. (1989) Summary page 2. - K882609: Models M1175A & M1176A Component Monitoring System, Waltham Div. Hewlett Packard (1989) Summary page 2. - K081937: Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry Module, Philips Medizin Systeme Boeblingen GmbH (2008) Summary page 2. - K091572: Disposable SPO2 Sensor M1134A, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2009) Summary page 2. - K062392: Philips MP5 Intellivue Patient Monitor, Philips Medizin Systeme Boeblingen GmbH (2006) Summary page 2. - K063725: MP5 Intellivue Patient Monitor, 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. - K072070: Philips MP2 and X2 Intellivue Patient Monitors, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2007) 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. - K083228: Philips Intellivue MP5 Patient Monitor, Philips Medizin Systeme Boblingen GmbH (2008) 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. - K091395: MP5 Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2009) 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. ## Most influential descendants - K111905: Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216 (2011), 36 descendants of its own - K122223: New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO (2013), 35 descendants of its own - K151736: Philips IntelliVue GuardianSoftware (2015), 24 descendants of its own - K161767: Philips IntelliVue GuardianSoftware (2017), 23 descendants of its own - K132320: Intellivue CL Respiration Pod (2014), 20 descendants of its own ## Indications for use The IntelliVue CL SpO 2 Pod is indicated for use by health care professionals whenever there is a need for monitoring the physiological patient parameters SpO2 and pulse rate wirelessly. The intended use of the IntelliVue CL SpO2 Pod when used together with IntelliVue Patient Monitors MP5, MP5T, MP2, X2, or with the IntelliVue Telemetry System Transceiver TRx4841A, is for monitoring, recording, and alarming arterial oxygen saturation and pulse rate of adult and pediatric patients inside hospitals. The device is intended for use by health care professionals. it is not intended for home use. The device is not a therapeutic device. The IntelliVue CL NBP Pod is indicated for use by health care professionals whenever there is a need for monitoring the physiological patient parameters non-invasive blood pressure and pulse rate wirelessly. The intended use of the IntelliVue CL NBP Pod when used together with IntelliVue Patient Monitors MP5, MP5T, MP2, X2, or with the IntelliVue Telemetry System Transceiver TRX4841A is for monitoring, recording, and alarming of systolic, diastolic, and mean pressure and pulse rate of adult and pediatric patients inside hospitals. The device is intended for use by health care professionals. It is not intended for home use. The device is not a therapeutic device. The IntelliVue Patient Monitors MP5, MP5T, MP2, X2 are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside of the hospital environment. The MP2, X2, and MP5 monitors are also intended for use during patient transport outside of the hospital environment. They are not intended for home use. The monitors are only for use on one patient at a time. They are not therapeutic devices. The IntelliVue Telemetry System Transceiver TRx4841A is indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended to provide ambulatory and bedside monitoring, recording and alarming of ECG and SpO2 parameters of adult and pediatric patients in transport and hospital environments. It is intended to be used by trained healthcare personnel. It is not intended for home use. The device is only for use on one patient at a time. It is not for use with infant or neonatal patients. Source page: https://510kreport.com/device/K101600 Methodology: https://510kreport.com/methodology