510(k) · Cleared
ClearedPhilips MP5 Intellivue Patient Monitor
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 Sep 6, 2006 as substantially equivalent to K041235 (Philips Medizin Systeme Boeblingen GmbH, 2004) and 13 other predicates after a 21-day review. Its family tree reaches back 23 generations to 1994. 176 later devices descend from it.
- Decided
- Sep 6, 2006
- Review
- 21 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 14
Its longest line of descent runs back 23 generations to K941811 (1994). 154 ancestors in all, the oldest K844187 (1985). 176 later devices descend from it, 25 citing it directly.
- Root · 23 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 19 generations between
- 3 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 2 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- 1 generation backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- This deviceK062392 Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006
- Descendant · cites it directly · 175 of its ownK063725 MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- Descendant · cites it directly · 151 of its ownK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- Descendant · cites it directly · 143 of its ownK081793 Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A…Philips Medizin Systeme Boeblingen GmbH · 2008
- Descendant · cites it directly · 127 of its ownK082633 Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2008 · Recalled
- Descendant · cites it directly · 125 of its ownK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
Show all 23 generations
- Root · 23 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 22 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 21 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 20 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 19 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 18 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 17 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 16 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 15 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 14 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 13 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 12 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 11 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
- 10 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- 9 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- 8 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- 7 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 6 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 5 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- 4 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- 3 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 2 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- 1 generation backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- This deviceK062392 Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006
Showing 5 of 176 descendants. See all descendants
Descendants cleared per year
2007high 18 (2025) · low 3 (2007)2026
Most influential descendants
Showing 5 of 176 · See all- K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · cites it directly175descendants
- K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · cites it directly151descendants
- K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH · 2008 · cites it directly143descendants
- K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2008 · cites it directly127descendants
- K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · cites it directly125descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −22 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −21 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −20 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −19 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −18 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −17 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −16 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −15 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −14 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −13 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −12 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −11 | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −10 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −9 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| −8 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −7 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −6 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −5 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −4 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −3 | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −2 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| −1 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
| 0 (this device) | K062392 | Philips MP5 Intellivue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| +1 | K063725 | MP5 Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
| +1 | K071426 | MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue… | 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 | — |
| +1 | K082633 | Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2008 | 3 |
| +1 | K083517 | Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 5 | 0 |
| 1991 | 6 | 0 |
| 1992 | 6 | 0 |
| 1993 | 5 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 7 | 0 |
| 1998 | 13 | 0 |
| 1999 | 9 | 0 |
| 2000 | 19 | 0 |
| 2001 | 6 | 0 |
| 2002 | 11 | 0 |
| 2003 | 9 | 0 |
| 2004 | 12 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 8 | 0 |
| 2013 | 10 | 0 |
| 2014 | 9 | 0 |
| 2015 | 7 | 0 |
| 2016 | 9 | 0 |
| 2017 | 10 | 0 |
| 2018 | 11 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 6 | 0 |
| 2022 | 14 | 0 |
| 2023 | 13 | 0 |
| 2024 | 13 | 0 |
| 2025 | 18 | 0 |
| 2026 | 10 | 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? (14)
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 |
|---|---|---|---|
| * | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsSummary page 2…dified device Philips MP5 IntelliVue Patient Monitor is substantially equivalent to previously cleared Philips MP30 IntelliVue Patient Monitor marketed pursuant to K041235, K042845, K050141, K051106, K052801, K052961, K052801, K053522, K060221, K060541, K061052, with Philips Multi-Parameter Mod… | 2004 |
| * | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsSummary page 2…e Philips MP5 IntelliVue Patient Monitor is substantially equivalent to previously cleared Philips MP30 IntelliVue Patient Monitor marketed pursuant to K041235, K042845, K050141, K051106, K052801, K052961, K052801, K053522, K060221, K060541, K061052, with Philips Multi-Parameter Module M3001… | 2004 |
| * | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient MonitorsSummary page 2…MP5 IntelliVue Patient Monitor is substantially equivalent to previously cleared Philips MP30 IntelliVue Patient Monitor marketed pursuant to K041235, K042845, K050141, K051106, K052801, K052961, K052801, K053522, K060221, K060541, K061052, with Philips Multi-Parameter Module M3001A markete… | 2005 |
| * | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsSummary page 2…lliVue Patient Monitor is substantially equivalent to previously cleared Philips MP30 IntelliVue Patient Monitor marketed pursuant to K041235, K042845, K050141, K051106, K052801, K052961, K052801, K053522, K060221, K060541, K061052, with Philips Multi-Parameter Module M3001A marketed pursuan… | 2005 |
| * | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…Summary page 2…tient Monitor is substantially equivalent to previously cleared Philips MP30 IntelliVue Patient Monitor marketed pursuant to K041235, K042845, K050141, K051106, K052801, K052961, K052801, K053522, K060221, K060541, K061052, with Philips Multi-Parameter Module M3001A marketed pursuant to [020… | 2005 |
| * | K052961 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors…Summary page 2…itor is substantially equivalent to previously cleared Philips MP30 IntelliVue Patient Monitor marketed pursuant to K041235, K042845, K050141, K051106, K052801, K052961, K052801, K053522, K060221, K060541, K061052, with Philips Multi-Parameter Module M3001A marketed pursuant to [020531, K030… | 2005 |
| * | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Summary page 2…tially equivalent to previously cleared Philips MP30 IntelliVue Patient Monitor marketed pursuant to K041235, K042845, K050141, K051106, K052801, K052961, K052801, K053522, K060221, K060541, K061052, with Philips Multi-Parameter Module M3001A marketed pursuant to [020531, K030973, K033715 and i… | 2006 |
| * | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Summary page 2…alent to previously cleared Philips MP30 IntelliVue Patient Monitor marketed pursuant to K041235, K042845, K050141, K051106, K052801, K052961, K052801, K053522, K060221, K060541, K061052, with Philips Multi-Parameter Module M3001A marketed pursuant to [020531, K030973, K033715 and its Philip… | 2006 |
| * | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsSummary page 2…previously cleared Philips MP30 IntelliVue Patient Monitor marketed pursuant to K041235, K042845, K050141, K051106, K052801, K052961, K052801, K053522, K060221, K060541, K061052, with Philips Multi-Parameter Module M3001A marketed pursuant to [020531, K030973, K033715 and its Philips M3014A… | 2006 |
| * | K061052 | The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Summary page 2…y cleared Philips MP30 IntelliVue Patient Monitor marketed pursuant to K041235, K042845, K050141, K051106, K052801, K052961, K052801, K053522, K060221, K060541, K061052, with Philips Multi-Parameter Module M3001A marketed pursuant to [020531, K030973, K033715 and its Philips M3014A Capnograp… | 2006 |
| * | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release…Summary page 2…1235, K042845, K050141, K051106, K052801, K052961, K052801, K053522, K060221, K060541, K061052, with Philips Multi-Parameter Module M3001A marketed pursuant to [020531, K030973, K033715 and its Philips M3014A Capnography Measurement Server Extension marketed pursuant to K050762 and K060221.… | 2002 |
| * | K030973 | Picosat II SPO2 Pulse Oximetry ModuleSummary page 2…K042845, K050141, K051106, K052801, K052961, K052801, K053522, K060221, K060541, K061052, with Philips Multi-Parameter Module M3001A marketed pursuant to [020531, K030973, K033715 and its Philips M3014A Capnography Measurement Server Extension marketed pursuant to K050762 and K060221. 4. Th… | 2003 |
| * | K033715 | Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement ServerSummary page 2…K050141, K051106, K052801, K052961, K052801, K053522, K060221, K060541, K061052, with Philips Multi-Parameter Module M3001A marketed pursuant to [020531, K030973, K033715 and its Philips M3014A Capnography Measurement Server Extension marketed pursuant to K050762 and K060221. 4. The modific… | 2004 |
| * | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Summary page 2…ulti-Parameter Module M3001A marketed pursuant to [020531, K030973, K033715 and its Philips M3014A Capnography Measurement Server Extension marketed pursuant to K050762 and K060221. 4. The modification is the introduction of the model MP5 IntelliVue Patient Monitor. 5. The modi… | 2005 |
What descends from it? (176)
See all 17625 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063725 | MP5 Intellivue Patient Monitor | 2007 | 175 |
| K071426 | MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient… | 2007 | 151 |
| K081793 | Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry… | 2008 | 143 |
| K082633 | Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50… | 2008 | 127 |
| K083517 | Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80… | 2009 | 125 |
| K091927 | Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 | 2009 | 124 |
| K100939 | Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70… | 2010 | 123 |
| K072070 | Philips MP2 and X2 Intellivue Patient Monitors | 2007 | 119 |
| K102562 | Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60… | 2010 | 103 |
| K082583 | Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80… | 2009 | 94 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 7 companies; a new generation was cleared every 3 months on median.
- 16 of the 154 ancestors have a recall of any class.
- Of its descendants, K063725 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2007) has gone furthest, with 175 descendants of its own.
- 31 other devices also cite its predicate K041235.
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.
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, pediatrics and neonates in hospital environments. The MP5 is also intended for use in transport situations within hospital environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062392: Philips MP5 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/K062392
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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