510(k) · Cleared
Recalled · Class II · 2025IntelliVue Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medizin Systeme Boeblingen GmbH · DSI Detector And Alarm, Arrhythmia
Cleared on Jul 17, 2015 as substantially equivalent to K141015 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2014) and 25 other predicates after a 25-day review. Its family tree reaches back 35 generations to 1994. 1 of the 265 devices in its family, counting itself, has a Class I recall. 32 later devices descend from it. It has been recalled 8 times.
- Decided
- Jul 17, 2015
- Review
- 25 days
- Class
- Class II
- Product code
- DSI
- Recalls
- 8
- Predicates
- 26
Its longest line of descent runs back 35 generations to K941811 (1994). 232 ancestors in all, the oldest K844187 (1985). 32 later devices descend from it, 1 citing it directly. 1 of the 265 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 deviceK151681 IntelliVue Patient MonitorPhilips 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 deviceK151681 IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2015
Showing 5 of 32 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 32 · 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) | K151681 | IntelliVue Patient Monitor | 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 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 7 | 0 |
| 1991 | 8 | 0 |
| 1992 | 7 | 0 |
| 1993 | 6 | 0 |
| 1994 | 2 | 0 |
| 1995 | 9 | 0 |
| 1996 | 10 | 0 |
| 1997 | 9 | 1 |
| 1998 | 17 | 0 |
| 1999 | 12 | 0 |
| 2000 | 20 | 0 |
| 2001 | 9 | 0 |
| 2002 | 16 | 0 |
| 2003 | 13 | 0 |
| 2004 | 16 | 0 |
| 2005 | 6 | 0 |
| 2006 | 7 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (26)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141015 | Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Summary page 9…K151681 Page 3 of 7 MX550 software Rev. K.20 marketed pursuant to K141015, K130849 and K131872 and the IntelliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, MX800 sof… | 2014 |
| * | K130849 | Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Summary page 9…K151681 Page 3 of 7 MX550 software Rev. K.20 marketed pursuant to K141015, K130849 and K131872 and the IntelliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, MX800 software Rev… | 2013 |
| * | K131872 | Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Summary page 9…Page 3 of 7 MX550 software Rev. K.20 marketed pursuant to K141015, K130849 and K131872 and the IntelliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, MX800 software Rev.J.08 market… | 2013 |
| * | K122439 | Intellivue Patient MonitorSummary page 9…1015, K130849 and K131872 and the IntelliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, MX800 software Rev.J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K… | 2012 |
| * | K120366 | Intellivue Patient MonitorSummary page 9…0849 and K131872 and the IntelliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, MX800 software Rev.J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K… | 2012 |
| * | K113441 | Physiological Monitor, Patient MonitorSummary page 9…K131872 and the IntelliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, MX800 software Rev.J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K… | 2012 |
| * | K113657 | Intellivue Patient MonitorSummary page 9…e IntelliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, MX800 software Rev.J.08 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K06372… | 2012 |
| * | K110474 | Philips Intellivue TCG10Summary page 9…telliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, MX800 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, K06228… | 2011 |
| * | K110622 | Intellivue Patient MonitorSummary page 9…Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, MX800 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, K… | 2011 |
| * | K102562 | Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Summary page 9…onitors MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, MX800 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, K… | 2010 |
| * | K101449 | Intellivue Patient MonitorSummary page 9…P40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, MX800 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, K… | 2010 |
| * | K100939 | Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Summary page 9…, MP60, MP70, MP80, MP90 and MX600, MX700, MX800 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, K… | 2010 |
| * | K093268 | Intellivue Patient MonitorSummary page 9…P70, MP80, MP90 and MX600, MX700, MX800 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.… | 2010 |
| * | K091927 | Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Summary page 9…, MP90 and MX600, MX700, MX800 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. The… | 2009 |
| * | K083517 | Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Summary page 9…00, MX700, MX800 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. The new G7m Gas An… | 2009 |
| * | K082633 | Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Summary page 9…MX700, MX800 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. The new G7m Gas Analyzer Mo… | 2008 |
| * | K081793 | Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Summary page 9…800 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. The new G7m Gas Analyzer Module (866… | 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, “IntelliVue Patient Monitors”. | 2007 |
| * | K071426 | MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Summary page 9….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. The new G7m Gas Analyzer Module (866173)is substantial… | 2007 |
| * | K063315 | Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90Summary page 9…ted 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. The new G7m Gas Analyzer Module (866173)is substantially equiva… | 2006 |
| * | K063725 | MP5 Intellivue Patient MonitorSummary page 9…ant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541. The new G7m Gas Analyzer Module (866173)is substantially equivalent to t… | 2007 |
| * | K062283 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsSummary page 9…22439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541. The new G7m Gas Analyzer Module (866173)is substantially equivalent to the legall… | 2006 |
| * | K062392 | Philips MP5 Intellivue Patient MonitorSummary page 9…, K113441, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541. The new G7m Gas Analyzer Module (866173)is substantially equivalent to the legally markete… | 2006 |
| * | K061610 | Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Summary page 9…, K113657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541. The new G7m Gas Analyzer Module (866173)is substantially equivalent to the legally marketed predica… | 2006 |
| * | K061052 | The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Summary page 9…13657, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541. The new G7m Gas Analyzer Module (866173)is substantially equivalent to the legally marketed predicate Philip… | 2006 |
| * | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsSummary page 9…10474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072020, K071426, K063315, K063725, K062283, K062392, K061610, K061052, K060541. The new G7m Gas Analyzer Module (866173)is substantially equivalent to the legally marketed predicate Philips G5 Gas… | 2006 |
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161531 | IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2… | 2016 | 31 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 31, 2025 | Class II | Z-0856-2026 | Use error | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Class II | Z-0854-2026 | Use error | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Class II | Z-0853-2026 | Use error | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Class II | Z-0858-2026 | Use error | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Class II | Z-0855-2026 | Use error | Potential issue where the IntelliVue monitors did not alarm. |
| Oct 31, 2025 | Class II | Z-0857-2026 | Use error | Potential issue where the IntelliVue monitors did not alarm. |
| Jan 18, 2023 | Class II | Z-0007-2025 | Under Investigation by firm | The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. This issue concerns the G7m's sample gas pump which could stop working, producing a technical, INOP… |
| Jun 25, 2020 | Class II | Z-2689-2020 | Software design | The device may experience an interruption of gas measurement due to a firmware issue, ceasing measurement and display of gas levels and generating one or more technical or INOP alarms. |
The 5 latest of 8 recalls; the web page lists all.
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.
- 40 of the 232 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 DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
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 MP40/MP50 monitors are additionally…
Read the full statement (788 words)
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 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 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 MX500/MX550 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 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) with the M1018A plug-in module 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151681: IntelliVue Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151681
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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