510(k) · Cleared
Recalled · Class II · 2014Intellivue MX40 Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phillips Medical Systems · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jan 7, 2011 as substantially equivalent to K040357 (Philips Medical Systems, Inc., 2004) and 4 other predicates after a 24-day review. Its family tree reaches back 26 generations to 1994. 16 later devices descend from it. It has been recalled once.
- Decided
- Jan 7, 2011
- Review
- 24 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 26 generations to K941811 (1994). 167 ancestors in all, the oldest K844187 (1985). 16 later devices descend from it, 3 citing it directly.
- Root · 26 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 22 generations between
- 3 generations backK062392 Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006
- 2 generations backK063725 MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- 1 generation backK081793 Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A…Philips Medizin Systeme Boeblingen GmbH · 2008
- This deviceK103646 Intellivue MX40 Patient MonitorPhillips Medical Systems · 2011
- Descendant · cites it directly · 14 of its ownK113125 Intellivue MX40 Patient MonitorPhilips Medical Systems · 2011 · Recalled
- Descendant · cites it directly · 13 of its ownK172226 MX40 Release B.07Philips Medical Systems · 2017
- Descendant · 2 generations on · 10 of its ownK193391 BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2020 · Recalled
- Descendant · 3 generations on · 3 of its ownK220058 BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2022 · Recalled
- Descendant · 3 generations on · 2 of its ownK223567 CNS-2101 Central MonitorNihon Kohden Corporation · 2023
Show all 26 generations
- Root · 26 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 25 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 24 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 23 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 22 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 21 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 20 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 19 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 18 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 17 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 16 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 15 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 14 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
- 13 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- 12 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- 11 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- 10 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 9 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 8 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- 7 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- 6 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 5 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- 4 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- 3 generations backK062392 Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006
- 2 generations backK063725 MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- 1 generation backK081793 Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A…Philips Medizin Systeme Boeblingen GmbH · 2008
- This deviceK103646 Intellivue MX40 Patient MonitorPhillips Medical Systems · 2011
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
2011high 3 (2025) · low 0 (2012)2026
Most influential descendants
Showing 5 of 16 · See all- K113125Intellivue MX40 Patient MonitorPhilips Medical Systems · 2011 · cites it directly14descendants
- K172226MX40 Release B.07Philips Medical Systems · 2017 · cites it directly13descendants
- K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2020 · 2 generations on10descendants
- K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2022 · 3 generations on3descendants
- K223567CNS-2101 Central MonitorNihon Kohden Corporation · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −25 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −24 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −23 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −22 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −21 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −20 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −19 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −18 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −17 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −16 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −15 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −14 | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −13 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −12 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| −11 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −10 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −9 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −8 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −7 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −6 | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −5 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| −4 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
| −3 | K062392 | Philips MP5 Intellivue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −2 | K063725 | MP5 Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
| −1 | K081793 | Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2008 | — |
| 0 (this device) | K103646 | Intellivue MX40 Patient Monitor | Phillips Medical Systems | 2011 | — |
| +1 | K113125 | Intellivue MX40 Patient Monitor | Philips Medical Systems | 2011 | 16 |
| +1 | K172226 | MX40 Release B.07 | Philips Medical Systems | 2017 | — |
| +2 | K193391 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020 | 2 |
| +3 | K220058 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022 | 1 |
| +3 | K223567 | CNS-2101 Central Monitor | Nihon Kohden Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 6 | 0 |
| 1991 | 6 | 0 |
| 1992 | 6 | 0 |
| 1993 | 5 | 0 |
| 1994 | 2 | 0 |
| 1995 | 6 | 0 |
| 1996 | 10 | 0 |
| 1997 | 7 | 0 |
| 1998 | 13 | 0 |
| 1999 | 10 | 0 |
| 2000 | 19 | 0 |
| 2001 | 6 | 0 |
| 2002 | 13 | 0 |
| 2003 | 11 | 0 |
| 2004 | 13 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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.
Planning a device in MHX? 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? (5)
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 |
|---|---|---|---|
| * | K040357 | M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…Summary page 1…DRO Radiofreguenc The. new device is substantially equivalent to the previously cleared TRx484lA, IntelliVue Telemetry System Transceiver mar 'keted pursuant to-K040357, K041741, K081793, K062392, and K063725. Intended for monitoring and recording of and to generate alarms for, multiple physiolog… | 2004 |
| * | K041741 | M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry…Summary page 1…Radiofreguenc The. new device is substantially equivalent to the previously cleared TRx484lA, IntelliVue Telemetry System Transceiver mar 'keted pursuant to-K040357, K041741, K081793, K062392, and K063725. Intended for monitoring and recording of and to generate alarms for, multiple physiological para… | 2004 |
| * | K081793 | Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Summary page 1…guenc The. new device is substantially equivalent to the previously cleared TRx484lA, IntelliVue Telemetry System Transceiver mar 'keted pursuant to-K040357, K041741, K081793, K062392, and K063725. Intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of… | 2008 |
| * | K062392 | Philips MP5 Intellivue Patient MonitorSummary page 1…he. new device is substantially equivalent to the previously cleared TRx484lA, IntelliVue Telemetry System Transceiver mar 'keted pursuant to-K040357, K041741, K081793, K062392, and K063725. Intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults a… | 2006 |
| * | K063725 | MP5 Intellivue Patient MonitorSummary page 1…is substantially equivalent to the previously cleared TRx484lA, IntelliVue Telemetry System Transceiver mar 'keted pursuant to-K040357, K041741, K081793, K062392, and K063725. Intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults and pediatrics… | 2007 |
What descends from it? (16)
See all 163 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 22, 2014 | Class II | Z-1746-2014 | Software design | IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 9 companies; a new generation was cleared every 4 months on median.
- 21 of the 167 ancestors have a recall of any class.
- Of its descendants, K113125 (Philips Medical Systems, 2011) has gone furthest, with 14 descendants of its own.
- 26 other devices also cite its predicate K040357.
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. 2011, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2007high 21 (2013) · low 5 (2021)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
2007high 248 (2014) · low 57 (2009)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
2007high 21 (2026) · low 0 (2020)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
2007high 3,761 (2025) · low 131 (2007)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?
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 and pediatrics in hospital environments and during transport inside hospitals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103646: Intellivue MX40 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/K103646
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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