510(k) · Cleared
Recalled · Class II · 2020Expression MR200 Mri Patient Monitoring System, Expression IP5 Information Portal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invivo Corporation · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jul 15, 2013 as substantially equivalent to K090785 (Invivo Corp., 2009) and 1 other predicate after a 62-day review. Its family tree reaches back 30 generations to 1994. It has been recalled 5 times.
- Decided
- Jul 15, 2013
- Review
- 62 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 30 generations to K941811 (1994). 195 ancestors in all, the oldest K832113 (1983). No later device cites it as a predicate yet.
- Root · 30 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 26 generations between
- 3 generations backK081937 Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules…Philips Medizin Systeme Boeblingen GmbH · 2008
- 2 generations backK090785 Mri Compatible Patient Monitoring System, Model 865214Invivo Corp. · 2009 · Recalled
- 1 generation backK121424 Expression Information PortalInvivo Corporation · 2012 · Recalled
- This deviceK131382 Expression MR200 Mri Patient Monitoring System, Expression IP5…Invivo Corporation · 2013
Show all 30 generations
- Root · 30 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 29 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 28 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 27 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 26 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 25 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 24 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 23 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 22 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 21 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 20 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 19 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 18 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
- 17 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- 16 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- 15 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- 14 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 13 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 12 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- 11 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- 10 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 9 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- 8 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- 7 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 6 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
- 5 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- 4 generations backK072070 Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- 3 generations backK081937 Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules…Philips Medizin Systeme Boeblingen GmbH · 2008
- 2 generations backK090785 Mri Compatible Patient Monitoring System, Model 865214Invivo Corp. · 2009 · Recalled
- 1 generation backK121424 Expression Information PortalInvivo Corporation · 2012 · Recalled
- This deviceK131382 Expression MR200 Mri Patient Monitoring System, Expression IP5…Invivo Corporation · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −30 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −29 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −28 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −27 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −26 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −25 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −24 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −23 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −22 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −21 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −20 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −19 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −18 | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −17 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −16 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| −15 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −14 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −13 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −12 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −11 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −10 | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −9 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| −8 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
| −7 | K061610 | Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −6 | K063315 | Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −5 | K071426 | MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
| −4 | K072070 | Philips MP2 and X2 Intellivue Patient Monitors | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
| −3 | K081937 | Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse… | Philips Medizin Systeme Boeblingen GmbH | 2008 | — |
| −2 | K090785 | Mri Compatible Patient Monitoring System, Model 865214 | Invivo Corp. | 2009 | 6 |
| −1 | K121424 | Expression Information Portal | Invivo Corporation | 2012 | 4 |
| 0 (this device) | K131382 | Expression MR200 Mri Patient Monitoring System, Expression IP5 Information… | Invivo Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 6 | 0 |
| 1991 | 7 | 0 |
| 1992 | 6 | 0 |
| 1993 | 6 | 0 |
| 1994 | 3 | 0 |
| 1995 | 9 | 0 |
| 1996 | 11 | 0 |
| 1997 | 8 | 0 |
| 1998 | 14 | 0 |
| 1999 | 10 | 0 |
| 2000 | 20 | 0 |
| 2001 | 7 | 0 |
| 2002 | 13 | 0 |
| 2003 | 13 | 0 |
| 2004 | 15 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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 |
|---|---|---|---|
| * | K090785 | Mri Compatible Patient Monitoring System, Model 865214Summary page 2…eared devices: Cleared Device Manufacturer 510(k) No. IClearance Date MRI Patient Monitoring System Invivo Corporation K090785 Dec 15, 2009 (Model 865214) Expression Information Portal_ Invivo Co oration K121424 Jun 13, 2012… | 2009 |
| * | K121424 | Expression Information PortalSummary page 2…MRI Patient Monitoring System Invivo Corporation K090785 Dec 15, 2009 (Model 865214) Expression Information Portal_ Invivo Co oration K121424 Jun 13, 2012 5.4 MODIFIED DEVICE DESCRIPTION The modified device, the Expression MR200 MRI Patient Monitoring Sys… | 2012 |
| † | K051366 | Piconibp Oem Module | 2005 |
| † | K053174 | Loflo C5 CO2 Sensor | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 18, 2020 | Class II | Z-2812-2020 | Nonconforming Material/Component | A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the… |
| Jun 18, 2020 | Class II | Z-2811-2020 | Nonconforming Material/Component | A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the… |
| Oct 22, 2014 | Class II | Z-0958-2015 | Component design/selection | The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock. |
| Sep 8, 2014 | Class II | Z-0001-2015 | Material/Component Contamination | During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to power up or loss of… |
| Sep 5, 2014 | Class II | Z-0069-2015 | Process control | Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 10 companies; a new generation was cleared every 4 months on median.
- 23 of the 195 ancestors have a recall of any class.
- 3 other devices also cite its predicate K090785.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The Expression MR200 MRI Patient Monitoring System (Model MR200) and the Expression IP5 Information Portal (Model IP5) are intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. The Expression MR200 MRI Patient Monitoring System (Model MR200) and the Expression IP5 Information Portal (Model IP5) are intended for use by healthcare professionals. The Expression MR200 MRI…
Read the full statement (100 words)
The Expression MR200 MRI Patient Monitoring System (Model MR200) and the Expression IP5 Information Portal (Model IP5) are intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.
The Expression MR200 MRI Patient Monitoring System (Model MR200) and the Expression IP5 Information Portal (Model IP5) are intended for use by healthcare professionals.
The Expression MR200 MRI Patient Monitoring System (Model MR200) and the Expression IP35 Information Portal (Model IPS) provide monitoring for the following vital sign parameters: EGG, pulse oximetry (Sp02), non-invasive blood pressure (NIBP), and optionally, carbon dioxide (002).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131382: Expression MR200 Mri Patient Monitoring System, Expression IP5 Information Portal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131382
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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