# K082633: Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 - Pathway: 510(k) (Special) - Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN - Decided: Oct 3, 2008 after 23 days - Product code: DSI (Detector And Alarm, Arrhythmia) - Device class: 2 - Regulation: 21 CFR 870.1025 - Recalls of this device: 3 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 25 generations back to K941811 (1994). 170 ancestors in all. 127 later devices descend from it; 20 cite it directly. 0 of 298 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K021778: Philips Component Compact Monitor, Release a.04, Model #M1275B, Philips Medical Systems (2002) 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. - K032858: The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O., Philips Medizin Systeme Boblingen GmbH (2003) Summary page 2. - K033444: Philips Medical Systems, M3012A- Hemodynamic Extension to the Multi-Measurement Server, Philips Medical Systems (2003) Summary page 2. - K033513: Easi Ecg Algorithm, Philips Medical Systems (2004) Summary page 2. - K040304: Philips Intellivue Patient Monitor, Models MP40 & MP50, Philips Medizin Systeme Boeblingen GmbH (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. - K041235: Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH (2004) 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. - K050762: Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 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. - 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. - K053522: Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00, Philips Medizin Systeme Boeblingen 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. - K060541: The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors, Philips Medizin Systeme Boblingen 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. - K061610: Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, 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. - K063315: Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90, Philips Medizin Systeme Boeblingen GmbH (2006) 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. ## Cited in the summary but kept off the family tree - K071426: MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient Monitors, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree - K072020: Restoration Adm System, Howmedica Osteonics Corp. (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree ## Most influential descendants - K083517: Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90 (2009), 125 descendants of its own - K091927: Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 (2009), 124 descendants of its own - K100939: Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 and MP90 (2010), 123 descendants of its own - K102562: Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800 (2010), 103 descendants of its own - K101449: Intellivue Patient Monitor (2010), 92 descendants of its own ## Recalls of this device - Nov 18, 2020 · Class II · Z-0544-2021: Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient. - Aug 31, 2010 · Not classified · Z-2625-2010: Speakers on the Philips IntelliVue X2 and MP2 patient monitors may fail, causing absence of an audible alarm and delaying patient treatment. - Oct 22, 2008 · Not classified · Z-0817-2009: Table Mounts assembled with incorrect length hardware may fall ## Indications for use Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MPS, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP2, X2 and MP5 are also intended for use during patient transport outside of a hospital environment. Source page: https://510kreport.com/device/K082633 Methodology: https://510kreport.com/methodology