510(k) · Cleared
ClearedIntelliVue Patient monitors MX400, MX450, MX500, MX550
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 Oct 17, 2025 as substantially equivalent to K223574 (Philips Medizin Systeme Boeblingen GmbH, 2023) and 1 other predicate after a 186-day review. Its family tree reaches back 41 generations to 1994. 2 of the 319 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 17, 2025
- Review
- 186 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 41 generations to K941811 (1994). 318 ancestors in all, the oldest K822055 (1982). No later device cites it as a predicate yet. 2 of the 319 devices in this family, counting this one, have a Class I recall.
- Root · 41 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 37 generations between
- 3 generations backK181314 IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement…Philips Medizin Systeme Boeblingen GmbH · 2018
- 2 generations backK182979 IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500…Philips Medizin Systeme Boeblingen GmbH · 2019
- 1 generation backK223574 IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH · 2023
- This deviceK251146 IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH · 2025
Show all 41 generations
- Root · 41 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 40 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 39 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 38 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 37 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 36 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 35 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 34 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 33 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 32 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 31 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 30 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 29 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
- 28 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- 27 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- 26 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- 25 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 24 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 23 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- 22 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- 21 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 20 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- 19 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- 18 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 17 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
- 16 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- 15 generations backK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
- 14 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
- 13 generations backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- 12 generations backK101449 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- 11 generations backK110622 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
- 10 generations backK113657 Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH · 2012
- 9 generations backK122439 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · Recalled
- 8 generations backK130849 Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · Recalled
- 7 generations backK141015 Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2014 · Recalled
- 6 generations backK150975 Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue…Philips Medizin Systeme Boeblingen GmbH · 2015 · Recalled
- 5 generations backK161531 IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and…Philips Medizin Systeme Boeblingen GmbH · 2016 · Recalled
- 4 generations backK171801 IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3…Philips Medizin Systeme Boeblingen GmbH · 2017 · Recalled
- 3 generations backK181314 IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement…Philips Medizin Systeme Boeblingen GmbH · 2018
- 2 generations backK182979 IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500…Philips Medizin Systeme Boeblingen GmbH · 2019
- 1 generation backK223574 IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH · 2023
- This deviceK251146 IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −41 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −40 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −39 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −38 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −37 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −36 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −35 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −34 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −33 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −32 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −31 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −30 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −29 | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −28 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −27 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| −26 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −25 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −24 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −23 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −22 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −21 | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −20 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| −19 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
| −18 | K061610 | Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −17 | K063315 | Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −16 | K071426 | MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
| −15 | K083517 | Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | 2 |
| −14 | K091927 | Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | — |
| −13 | K100939 | Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| −12 | K101449 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| −11 | K110622 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | 2 |
| −10 | K113657 | Intellivue Patient Monitor | Philips Medizin Systeme Boblingen GmbH | 2012 | — |
| −9 | K122439 | Intellivue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2012 | 4 |
| −8 | K130849 | Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2013 | 8 |
| −7 | K141015 | Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2014 | 1 |
| −6 | K150975 | Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2… | Philips Medizin Systeme Boeblingen GmbH | 2015 | 1 |
| −5 | K161531 | IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement… | Philips Medizin Systeme Boeblingen GmbH | 2016 | 1 |
| −4 | K171801 | IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue… | Philips Medizin Systeme Boeblingen GmbH | 2017 | 4 |
| −3 | K181314 | IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3… | Philips Medizin Systeme Boeblingen GmbH | 2018 | — |
| −2 | K182979 | IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550… | Philips Medizin Systeme Boeblingen GmbH | 2019 | — |
| −1 | K223574 | IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450… | Philips Medizin Systeme Boeblingen GmbH | 2023 | — |
| 0 (this device) | K251146 | IntelliVue Patient monitors MX400, MX450, MX500, MX550 | Philips Medizin Systeme Boeblingen GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 8 | 0 |
| 1991 | 8 | 0 |
| 1992 | 7 | 0 |
| 1993 | 6 | 0 |
| 1994 | 3 | 0 |
| 1995 | 10 | 0 |
| 1996 | 10 | 0 |
| 1997 | 9 | 1 |
| 1998 | 17 | 0 |
| 1999 | 12 | 0 |
| 2000 | 25 | 0 |
| 2001 | 11 | 0 |
| 2002 | 21 | 0 |
| 2003 | 16 | 0 |
| 2004 | 23 | 0 |
| 2005 | 11 | 0 |
| 2006 | 14 | 0 |
| 2007 | 7 | 0 |
| 2008 | 6 | 0 |
| 2009 | 7 | 0 |
| 2010 | 11 | 0 |
| 2011 | 8 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 1 |
| 2017 | 2 | 0 |
| 2018 | 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.
2 devices in this family have 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? (2)
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 |
|---|---|---|---|
| * | K223574 | IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Summary page 6…IntelliVue Patient Monitor MX400 IntelliVue Patient Monitor MX450 K223574 Philips MHX IntelliVue Pa… | 2023 |
| * | K180881 | HemoSphere Advanced Monitor, HemoSphere Pressure CableSummary page 6…HemoSphere Swan-Ganz Module, Edwards HemoSphere K180881 DQK Lifesciences Oximetry Cabl… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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.
- K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2016 · 2 generations back · ◆ in the 2016 ancestors bar of FIG. 11 Class I recall
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 11 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 8 companies; a new generation was cleared every 5 months on median.
- 62 of the 318 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K223574.
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. 2025, 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?
Intended Use: The devices are intended to be used for monitoring and recording of, and to generate alarms for multiple physiological parameters of adults, pediatrics, and neonates. Indications for Use 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 only for use on one patient at a time. The monitors are not therapeutic devices. The monitors…
Read the full statement (706 words)
Intended Use:
The devices are intended to be used for monitoring and recording of, and to generate alarms for multiple physiological parameters of adults, pediatrics, and neonates.
Indications for Use
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 only for use on one patient at a time.
The monitors are 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 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 is intended to be used as an objective neuromuscular transmission monitor that measures the muscle response to electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.
The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), 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.
The non-invasive Masimo O3 Regional Oximeter System and accessories are indicated for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and <40 kg, in healthcare environments.
The SedLine Sedation Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The agents include: Alfentanil, Desflurane, Fentanyl, Isoflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The SedLine Sedation Monitor is intended for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.
The Edwards FloTrac solution offers continuous assessment of hemodynamic parameters. It is indicated to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is indicated for use in adult critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. The Edwards FloTrac solution is indicated to be used in the operating room, intensive care unit, and emergency room.
The monitors are intended for use by trained healthcare professionals in a hospital environment.
They are not intended for home use.
The monitors are additionally intended for use in transport situations within hospital environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251146: IntelliVue Patient monitors MX400, MX450, MX500, MX550.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251146
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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