# K113441: Physiological Monitor, Patient Monitor - Pathway: 510(k) (Traditional) - Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN - Decided: Mar 22, 2012 after 122 days - Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)) - Device class: 2 - Regulation: 21 CFR 870.1025 - 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: 31 generations back to K941811 (1994). 194 ancestors in all. 78 later devices descend from it; 10 cite it directly. 0 of 273 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K110622: Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2011) Summary page 3. - K110474: Philips Intellivue TCG10, 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. - K101449: Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2010) Summary page 3. - 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 3. - K093268: Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2010). Our reading of the summary gave K093260, FDA’s number for Aeronox Nitric Oxide Titration & Monitoring System (International Biomedical, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Philips IntelliVue patient monitors”. - K091927: Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90, 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. - 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. - 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. - K062283: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient Monitors, Philips Medical Systems North America, Inc. (2006) Summary page 3. - K062392: Philips MP5 Intellivue Patient Monitor, Philips Medizin Systeme Boeblingen GmbH (2006) Summary page 3. - K061610: Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH (2006) Summary page 3. - K061052: The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90, Philips Medical Systems North America, Inc. (2006) Summary page 3. - K060541: The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors, Philips Medizin Systeme Boblingen GmbH (2006) Summary page 3. - K060221: The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH (2006) Summary page 3. - K053522: Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00, Philips Medizin Systeme Boeblingen GmbH (2006) Summary page 3. - 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 3. - K051106: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH (2005) Summary page 3. - K050762: Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90, Philips Medizin Systeme Boeblingen GmbH (2005) Summary page 3. - K050141: The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH (2005) Summary page 3. - K042845: The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors, Philips Medizin Systeme Boblingen GmbH (2004) Summary page 3. - K041235: Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH (2004) Summary page 3. - K040304: Philips Intellivue Patient Monitor, Models MP40 & MP50, Philips Medizin Systeme Boeblingen GmbH (2004) Summary page 3. - K033513: Easi Ecg Algorithm, Philips Medical Systems (2004) Summary page 3. - K033444: Philips Medical Systems, M3012A- Hemodynamic Extension to the Multi-Measurement Server, Philips Medical Systems (2003) Summary page 3. - K032858: The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O., Philips Medizin Systeme Boblingen GmbH (2003) Summary page 3. - K031481: The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20, Philips Medizin Systeme Boblingen GmbH (2003) Summary page 3. - 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 3. - K023871: M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient Monitor with Portal Technology, Philips Medical Systems (2002) Summary page 3. - K021778: Philips Component Compact Monitor, Release a.04, Model #M1275B, Philips Medical Systems (2002) Summary page 3. ## Most influential descendants - K122439: Intellivue Patient Monitor (2012), 41 descendants of its own - K131872: Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550 (2013), 37 descendants of its own - K130849: Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450 (2013), 37 descendants of its own - K141015: Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient Monitor MX500, Intellivue Patient (2014), 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 ## Recalls of this device - Apr 7, 2025 · Class II · Z-1722-2025: Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible. ## 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, MP5, MPST, MP5SC, X2, MP2O, MP3O, MP4O, and MP50 are additionally intended for use in transport situations within hospital environments. The MP2, X2 and MPB are also intended for use during patient transport outside of a hospital environment. The Integrated Pulmonary Index (IPT) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPT is an adjunct to and not intended to replace vital sign monitoring. Source page: https://510kreport.com/device/K113441 Methodology: https://510kreport.com/methodology