510(k) · Cleared
Recalled · Class II · 2017Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medizin Systeme Boeblingen GmbH · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jun 25, 2015 as substantially equivalent to K141015 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2014) and 38 other predicates after a 73-day review. Its family tree reaches back 35 generations to 1994. 1 of the 293 devices in its family, counting itself, has a Class I recall. 34 later devices descend from it. It has been recalled once.
- Decided
- Jun 25, 2015
- Review
- 73 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 40
Its longest line of descent runs back 35 generations to K941811 (1994). 258 ancestors in all, the oldest K844187 (1985). 34 later devices descend from it, 2 citing it directly. 1 of the 293 devices in this family, counting this one, has a Class I recall.
- Root · 35 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 31 generations between
- 3 generations backK122439 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · Recalled
- 2 generations backK130849 Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · Recalled
- 1 generation backK141015 Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2014 · Recalled
- This deviceK150975 Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue…Philips Medizin Systeme Boeblingen GmbH · 2015
- Descendant · cites it directly · 31 of its ownK161531 IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and…Philips Medizin Systeme Boeblingen GmbH · 2016 · Recalled
- Descendant · 2 generations on · 8 of its ownK171801 IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3…Philips Medizin Systeme Boeblingen GmbH · 2017 · Recalled
- Descendant · 2 generations on · 6 of its ownK221704 HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP)…Edwards Lifesciences, LLC · 2022
- Descendant · 2 generations on · 6 of its ownK210906 IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850…Philips Medizin Systeme Boeblingen GmbH · 2021 · Recalled
- Descendant · 2 generations on · 6 of its ownK181314 IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement…Philips Medizin Systeme Boeblingen GmbH · 2018
Show all 35 generations
- Root · 35 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 34 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 33 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 32 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 31 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 30 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 29 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 28 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 27 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 26 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 25 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 24 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 23 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
- 22 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- 21 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- 20 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- 19 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 18 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 17 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- 16 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- 15 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 14 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- 13 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- 12 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 11 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
- 10 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- 9 generations backK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
- 8 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
- 7 generations backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- 6 generations backK101449 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- 5 generations backK110622 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
- 4 generations backK113657 Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH · 2012
- 3 generations backK122439 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · Recalled
- 2 generations backK130849 Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · Recalled
- 1 generation backK141015 Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2014 · Recalled
- This deviceK150975 Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue…Philips Medizin Systeme Boeblingen GmbH · 2015
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K970209 Capnocheck Plus7 generations back · 1997
Most influential descendants
Showing 5 of 34 · See all- K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH · 2016 · cites it directly31descendants
- K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH · 2017 · 2 generations on8descendants
- K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC · 2022 · 2 generations on6descendants
- K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH · 2021 · 2 generations on6descendants
- K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH · 2018 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −35 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −34 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −33 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −32 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −31 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −30 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −29 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −28 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −27 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −26 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −25 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −24 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −23 | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −22 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −21 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| −20 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −19 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −18 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −17 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −16 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −15 | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −14 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| −13 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
| −12 | K061610 | Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −11 | K063315 | Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −10 | K071426 | MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
| −9 | K083517 | Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | 2 |
| −8 | K091927 | Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | — |
| −7 | K100939 | Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| −6 | K101449 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| −5 | K110622 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | 2 |
| −4 | K113657 | Intellivue Patient Monitor | Philips Medizin Systeme Boblingen GmbH | 2012 | — |
| −3 | K122439 | Intellivue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2012 | 4 |
| −2 | K130849 | Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2013 | 8 |
| −1 | K141015 | Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2014 | 1 |
| 0 (this device) | K150975 | Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2… | Philips Medizin Systeme Boeblingen GmbH | 2015 | — |
| +1 | K161531 | IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement… | Philips Medizin Systeme Boeblingen GmbH | 2016 | 1 |
| +2 | K171801 | IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue… | Philips Medizin Systeme Boeblingen GmbH | 2017 | 4 |
| +2 | K221704 | HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global… | Edwards Lifesciences, LLC | 2022 | — |
| +2 | K210906 | IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue… | Philips Medizin Systeme Boeblingen GmbH | 2021 | 2 |
| +2 | K181314 | IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3… | Philips Medizin Systeme Boeblingen GmbH | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 7 | 0 |
| 1991 | 8 | 0 |
| 1992 | 7 | 0 |
| 1993 | 6 | 0 |
| 1994 | 3 | 0 |
| 1995 | 9 | 0 |
| 1996 | 10 | 0 |
| 1997 | 9 | 1 |
| 1998 | 17 | 0 |
| 1999 | 12 | 0 |
| 2000 | 20 | 0 |
| 2001 | 10 | 0 |
| 2002 | 17 | 0 |
| 2003 | 14 | 0 |
| 2004 | 19 | 0 |
| 2005 | 9 | 0 |
| 2006 | 10 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (40)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141015 | Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Summary page 10…tware Rev. L.02 are substantially equivalent to the previously cleared IntelliVue Patient Monitors MX400, MX450, MX500, and MX550 software Rev. K.20 marketed pursuant to K141015, K130849 and K131872 and the IntelliVue Patient Monitors MP2, MP5, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 and MX60… | 2014 |
| * | K130849 | Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Summary page 10…. L.02 are substantially equivalent to the previously cleared IntelliVue Patient Monitors MX400, MX450, MX500, and MX550 software Rev. K.20 marketed pursuant to K141015, K130849 and K131872 and the IntelliVue Patient Monitors MP2, MP5, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700,… | 2013 |
| * | K131872 | Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Summary page 10…ubstantially equivalent to the previously cleared IntelliVue Patient Monitors MX400, MX450, MX500, and MX550 software Rev. K.20 marketed pursuant to K141015, K130849 and K131872 and the IntelliVue Patient Monitors MP2, MP5, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, MX800 and I… | 2013 |
| * | K122439 | Intellivue Patient MonitorSummary page 10…MP2, MP5, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, MX800 and IntelliVue X2 Multi-Measurement Module software Rev.J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K0… | 2012 |
| * | K120366 | Intellivue Patient MonitorSummary page 10…MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, MX800 and IntelliVue X2 Multi-Measurement Module software Rev.J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K0… | 2012 |
| * | K113441 | Physiological Monitor, Patient MonitorSummary page 10…P20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, MX800 and IntelliVue X2 Multi-Measurement Module software Rev.J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K0… | 2012 |
| * | K113657 | Intellivue Patient MonitorSummary page 10…, MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, MX800 and IntelliVue X2 Multi-Measurement Module software Rev.J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K0… | 2012 |
| * | K110474 | Philips Intellivue TCG10Summary page 10…P50, MP60, MP70, MP80, MP90 and MX600, MX700, MX800 and IntelliVue X2 Multi-Measurement Module software Rev.J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K0… | 2011 |
| * | K110622 | Intellivue Patient MonitorSummary page 10…, MP70, MP80, MP90 and MX600, MX700, MX800 and IntelliVue X2 Multi-Measurement Module software Rev.J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K0… | 2011 |
| * | K102562 | Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Summary page 10…P80, MP90 and MX600, MX700, MX800 and IntelliVue X2 Multi-Measurement Module software Rev.J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K0… | 2010 |
| * | K101449 | Intellivue Patient MonitorSummary page 10…and MX600, MX700, MX800 and IntelliVue X2 Multi-Measurement Module software Rev.J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K0… | 2010 |
| * | K100939 | Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Summary page 10…0, MX700, MX800 and IntelliVue X2 Multi-Measurement Module software Rev.J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K0… | 2010 |
| * | K093268 | Intellivue Patient MonitorSummary page 10…MX800 and IntelliVue X2 Multi-Measurement Module software Rev.J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K0… | 2010 |
| * | K091927 | Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Summary page 10…d IntelliVue X2 Multi-Measurement Module software Rev.J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K0… | 2009 |
| * | K083517 | Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Summary page 10…Vue X2 Multi-Measurement Module software Rev.J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K0… | 2009 |
| * | K082633 | Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Summary page 10…lti-Measurement Module software Rev.J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K0… | 2008 |
| * | K081793 | Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Summary page 10…rement Module software Rev.J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K0… | 2008 |
| * | K072070 | Philips MP2 and X2 Intellivue Patient Monitors Our reading of the summary gave K072020, FDA’s number for Restoration Adm System (Howmedica Osteonics Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Philips IntelliVue Patient Monitors and IntelliVue X2…”. | 2007 |
| * | K071426 | MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Summary page 10…ware Rev.J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K0… | 2007 |
| * | K063315 | Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90Summary page 10…J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K0… | 2006 |
| * | K063725 | MP5 Intellivue Patient MonitorSummary page 10…eted pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K0… | 2007 |
| * | K062283 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsSummary page 10…uant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K032858, K0… | 2006 |
| * | K062392 | Philips MP5 Intellivue Patient MonitorSummary page 10…122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K032858, K031481, K0… | 2006 |
| * | K061610 | Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Summary page 10…120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K032858, K031481, K030038 and… | 2006 |
| * | K061052 | The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Summary page 10…113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K032858, K031481, K030038 and K021788.… | 2006 |
| * | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsSummary page 10…113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K032858, K031481, K030038 and K021788. The mod… | 2006 |
| * | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Summary page 10…110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K032858, K031481, K030038 and K021788. The modified Phi… | 2006 |
| * | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Summary page 10…110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K032858, K031481, K030038 and K021788. The modified Philips X1 (… | 2006 |
| * | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…Summary page 10…102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K032858, K031481, K030038 and K021788. The modified Philips X1 (M3001AL)… | 2005 |
| * | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsSummary page 10…101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K032858, K031481, K030038 and K021788. The modified Philips X1 (M3001AL) and X2 Mu… | 2005 |
| * | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Summary page 10…100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K032858, K031481, K030038 and K021788. The modified Philips X1 (M3001AL) and X2 Multi-Measu… | 2005 |
| * | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient MonitorsSummary page 10…093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K032858, K031481, K030038 and K021788. The modified Philips X1 (M3001AL) and X2 Multi-Measurement Mo… | 2005 |
| * | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsSummary page 10…091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K032858, K031481, K030038 and K021788. The modified Philips X1 (M3001AL) and X2 Multi-Measurement Modules and… | 2004 |
| * | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsSummary page 10…083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K032858, K031481, K030038 and K021788. The modified Philips X1 (M3001AL) and X2 Multi-Measurement Modules and Philips… | 2004 |
| * | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50Summary page 10…082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K032858, K031481, K030038 and K021788. The modified Philips X1 (M3001AL) and X2 Multi-Measurement Modules and Philips MP2 and M… | 2004 |
| * | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O.Summary page 10…081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K032858, K031481, K030038 and K021788. The modified Philips X1 (M3001AL) and X2 Multi-Measurement Modules and Philips MP2 and MP5/MP5SC… | 2003 |
| * | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Summary page 10…072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K032858, K031481, K030038 and K021788. The modified Philips X1 (M3001AL) and X2 Multi-Measurement Modules and Philips MP2 and MP5/MP5SC patient m… | 2003 |
| * | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…Summary page 10…071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K032858, K031481, K030038 and K021788. The modified Philips X1 (M3001AL) and X2 Multi-Measurement Modules and Philips MP2 and MP5/MP5SC patient monitors a… | 2003 |
| Kept off the family tree | K021788 | FDA’s K021788 is NBD Cement Restrictor Device Our reading of the summary gave K021788, FDA’s number for NBD Cement Restrictor Device (New Business Development, LLC). Its FDA name has none of the distinctive words the summary uses for the device it names, “Philips IntelliVue Patient Monitors and IntelliVue X2…”. Kept off the family tree. Summary page 10…315, K063725, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K032858, K031481, K030038 and K021788. The modified Philips X1 (M3001AL) and X2 Multi-Measurement Modules and Philips MP2 and MP5/MP5SC patient monitors are substanti… | 2002 |
| * | K120657 | Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsSummary page 11…lly marketed IntelliVue patient monitor MP40, MP50, MP60, MP70, MP80, MP90, MX600, MX700 or MX800 with a Masimo rainbow SET® Radical 7 Pulse CO-Oximeter (as cleared with K120657) connected via the M1032A Vuelink interface. 4.) Description of the Devices: The subject devices Philips IntelliVue Patient Mon… | 2012 |
What descends from it? (34)
See all 342 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 23, 2017 | Class II | Z-0292-2018 | Software design | Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 7 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 8 companies; a new generation was cleared every 4 months on median.
- 45 of the 258 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K161531 (Philips Medizin Systeme Boeblingen GmbH, 2016) has gone furthest, with 31 descendants of its own.
- 1 other device also cites its predicate K141015.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The Philips IntelliVue MP2 is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The Philips IntelliVue MP2 is intended to be used for monitoring and recording of, and to generate alarms, for, multiple physiological parameters of adults, pediatrics, and neonates. It is intended for use by trained healthcare professionals in a hospital environment. The MP2 is also intended for…
Read the full statement (1,518 words)
The Philips IntelliVue MP2 is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.
The Philips IntelliVue MP2 is intended to be used for monitoring and recording of, and to generate alarms, for, multiple physiological parameters of adults, pediatrics, and neonates. It is intended for use by trained healthcare professionals in a hospital environment.
The MP2 is also intended for use during patient transport inside and outside of the hospital environment.
The MP2 is only for use on one patient at a time. They are not intended for home use. Not a therapeutic device. The Philips IntelliVue MP2/X2 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 AAMI 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 Philips IntelliVue X2 is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.
The X2 is intended to be used for monitoring and recording of, and to generate alarms, for, multiple physiological parameters of adults, pediatrics, and neonates. It is intended for use by trained healthcare professionals in a hospital environment.
The X2 is also intended for use during patient transport inside and outside of the hospital environment.
The Philips IntelliVue X2 is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The Philips IntelliVue X2 is 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 AAMI 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 Integrated Pulmonary Index (IPI) 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 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 ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI 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 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 (IPI) 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.
The monitors are indicated for use by healthcare 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 MX400/MX450/MX500/MX550 are additionally intended for use in transport situations within hospital environments.
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 AAMI EC11).
ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only.
BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation
The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.
The Integrated Pulmonary Index (IPI) 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.
The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.
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 MP20/MP30/MP40/MP50 monitors are additionally intended for use in transport situations within hospital environments.
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 AAMI 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 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.
The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only.
BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents.
Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.
The Integrated Pulmonary Index (IPI) 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 IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.
The Indications for Use as specified for the IntelliVue patient monitor applies.
The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2 ), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150975 · printed Nov 3, 2026
Cite this page
510(k) Report. “K150975: Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K150975
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026