510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Mri Compatible Patient Monitoring System, Model 865214

K090785510(k) SpecialCleared Dec 15, 2009267-day reviewClass II21 CFR 870.2300Recalls 6

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Invivo Corp. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Cleared on Dec 15, 2009 as substantially equivalent to K053462 (Invivo Corporation, 2006) and 1 other predicate after a 267-day review. Its family tree reaches back 28 generations to 1994. 9 later devices descend from it. It has been recalled 6 times.

Decided
Dec 15, 2009
Review
267 days
Class
Class II
Product code
MWI
Recalls
6
Predicates
2

Its longest line of descent runs back 28 generations to K941811 (1994). 193 ancestors in all, the oldest K832113 (1983). 9 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 5 other ancestors2005: 3 other ancestors2004: 15 other ancestors2002: 13 other ancestors2007: 1 other ancestor2003: 13 other ancestors2001: 7 other ancestors2000: 20 other ancestors1998: 14 other ancestors1995: 9 other ancestors1994: 3 other ancestors1999: 10 other ancestors1997: 8 other ancestors1996: 11 other ancestors1993: 6 other ancestors1992: 6 other ancestors1991: 7 other ancestors1990: 6 other ancestors1989: 3 other ancestors1988: 1 other ancestor1987: 2 other ancestors1983: 1 other ancestor1985: 1 other ancestor2013: 3 descendants cleared2012: 1 descendant cleared2011: 1 descendant cleared2021: 1 descendant cleared2015: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant clearedK941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996×3: 3 generations cleared close together, K981376 (1999), K990125 (1999), K990972 (1999) ×20: 20 generations cleared close together, K013199 (2001), K020531 (2002), K021778 (2002), K023871 (2002), K030038 (2003), K031481 (2003), K032858 (2003), K040304 (2004), K041235 (2004), K042845 (2004), K050141 (2005), K050762 (2005), K051106 (2005), K052801 (2005), K053522 (2006), K060221 (2006), K060541 (2006), K061052 (2006), K061610 (2006), K063315 (2006) ×2: 2 generations cleared close together, K071426 (2007), K072070 (2007) K081937 · Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry Module · Philips Medizin Systeme Boeblingen GmbH · 200819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 6 other ancestors3 generations back: 14 other ancestors4 generations back: 34 other ancestors5 generations back: 33 other ancestors6 generations back: 26 other ancestors7 generations back: 16 other ancestors8 generations back: 14 other ancestors9 generations back: 12 other ancestors10 generations back: 8 other ancestors11 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants K081937 · Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry Module · Philips Medizin Systeme Boeblingen GmbH · 2008K072070 · Philips MP2 and X2 Intellivue Patient Monitors · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007K071426 · MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient Monitors · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007K063315 · Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2006K061610 · Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2006K061052 · The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 · Philips Medical Systems North America, Inc. · 2006K060541 · The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors · Philips Medizin Systeme Boblingen GmbH · 2006 · recalledK060221 · The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2006K053522 · Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00 · Philips Medizin Systeme Boeblingen GmbH · 2006K052801 · Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2005K051106 · The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2005K050762 · Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2005K050141 · The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2005K042845 · The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boblingen GmbH · 2004K041235 · Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2004K040304 · Philips Intellivue Patient Monitor, Models MP40 & MP50 · Philips Medizin Systeme Boeblingen GmbH · 2004K032858 · The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O. · Philips Medizin Systeme Boblingen GmbH · 2003K031481 · The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 · Philips Medizin Systeme Boblingen GmbH · 2003K030038 · Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185 Opt C41 Wireless Bedside Adaptr · Philips Medical Systems, Inc. · 2003K023871 · M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient Monitor with Portal Technology · Philips Medical Systems · 2002K021778 · Philips Component Compact Monitor, Release a.04, Model #M1275B · Philips Medical Systems · 2002K020531 · Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release a.02, Model M1275B · Philips Medical Systems · 2002K013199 · Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B · Philips Medical Systems, Inc. · 2001K990972 · HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable T · Hewlett-Packard GmbH · 1999K990125 · HP Viridia Component Monitoring System, Model Rev. K · Hewlett-Packard GmbH · 1999K981376 · Hewlett-Packard M1205A Viridia 24 CT · Hewlett-Packard Co. · 1999K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996K941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994−25−20−15−10−50
  1. Root · 28 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 24 generations between
  3. 3 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  4. 2 generations backK072070 Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  5. 1 generation backK081937 Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules…Philips Medizin Systeme Boeblingen GmbH · 2008
  6. This deviceK090785 Mri Compatible Patient Monitoring System, Model 865214Invivo Corp. · 2009
  7. Descendant · cites it directly · 4 of its ownK124061 Mri Patient Monitoring System (Model 865214)Invivo Corporation · 2013 · Recalled
  8. Descendant · 2 generations on · 2 of its ownK152330 Expression MR400 MRI Patient Monitoring SystemInvivo Corporation · 2015 · Recalled
  9. Descendant · cites it directly · 2 of its ownK121424 Expression Information PortalInvivo Corporation · 2012 · Recalled
  10. Descendant · 3 generations on · 0 of its ownK212271 smart-syncNorthh Medical GmbH · 2022
  11. Descendant · 2 generations on · 0 of its ownK212227 Philips MR Patient Care PortalInvivo Corporation · 2021 · Recalled
Show all 28 generations
  1. Root · 28 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 27 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 26 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 25 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 24 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 23 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 22 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 21 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 20 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 19 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 18 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 17 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 16 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 15 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 14 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 13 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 12 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 11 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 10 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 9 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 8 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  22. 7 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  23. 6 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
  24. 5 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  25. 4 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
  26. 3 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  27. 2 generations backK072070 Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  28. 1 generation backK081937 Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules…Philips Medizin Systeme Boeblingen GmbH · 2008
  29. This deviceK090785 Mri Compatible Patient Monitoring System, Model 865214Invivo Corp. · 2009

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12013: 32015: 12018: 12021: 12022: 1
2011high 3 (2013) · low 0 (2014)2026

Most influential descendants

Showing 5 of 9 · See all
  • K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation · 2013 · cites it directly4descendants
  • K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation · 2015 · 2 generations on2descendants
  • K121424Expression Information PortalInvivo Corporation · 2012 · cites it directly2descendants
  • K212271smart-syncNorthh Medical GmbH · 2022 · 3 generations on0descendants
  • K212227Philips MR Patient Care PortalInvivo Corporation · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−28K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−27K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−26K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−25K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−24K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−23K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−22K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−21K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−20K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−19K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−18K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−17K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−16K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−15K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−14K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−13K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−12K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−11K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−10K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−9K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−8K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−7K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
−6K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—
−5K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−4K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80…Philips Medizin Systeme Boeblingen GmbH2006—
−3K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
−2K072070Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
−1K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse…Philips Medizin Systeme Boeblingen GmbH2008—
0 (this device)K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.2009—
+1K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation20131
+2K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation20151
+1K121424Expression Information PortalInvivo Corporation20124
+3K212271smart-syncNorthh Medical GmbH2022—
+2K212227Philips MR Patient Care PortalInvivo Corporation20211

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198510
198720
198810
198930
199060
199170
199260
199360
199430
199590
1996110
199780
1998140
1999100
2000200
200170
2002130
2003130
2004150
200530
200650
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201330
201510
201810
202110
202210
FIG. 1 — Lineage of K090785, 1994–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K0534623160 Mri Patient Monitoring System
Summary page 3
…: Predic'ate Device Manuifactturer' 510(K Nb.' _Cliearanc Dt 13160 MRI Patient Monitoring System Invivo Corpraio K053462 IJanuary IS8, 2006 PICOSAT 1I SpO2 Pulse Oximetry Philips Medical K08 1937 August 29, 2008 Mod…
Invivo Corporation20062
*K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…
Summary page 3
…13160 MRI Patient Monitoring System Invivo Corpraio K053462 IJanuary IS8, 2006 PICOSAT 1I SpO2 Pulse Oximetry Philips Medical K08 1937 August 29, 2008 Module Systems COMPARISON TO PREDICATE DEVICE The Expression MR1 Patient…
Philips Medizin Systeme Boeblingen GmbH2008—

Also cleared against K053462: 2 other devices →

What descends from it? (9)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation20134
K121424Expression Information PortalInvivo Corporation20122
K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation20130
K103700Essential Mri Patient MonitorInvivo Corporation20110

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 18, 2020Class IIZ-2812-2020Nonconforming Material/ComponentA 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, 2020Class IIZ-2810-2020Nonconforming Material/ComponentA 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, 2020Class IIZ-2811-2020Nonconforming Material/ComponentA 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…
Apr 13, 2020Class IIZ-2244-2020Under Investigation by firmThe labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
Oct 15, 2012Class IIZ-0468-2013Nonconforming Material/ComponentInvivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression MRI Patient Monitoring System because during transport of the systems cart with a docked Display Controller Unit (DCU), a caster (wheel)…
Aug 30, 2010Not classifiedZ-0106-2012Device DesignPhilips Invivo Corporation of Orlando, FL is recalling their Expression MRI Patient Monitoring System. During transport of the system's cart with a docked Display Controller Unit (DCU), a front caster (wheel) may become loose and fall off…

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 15 years and passes through 9 companies; a new generation was cleared every 3 months on median.
  • 21 of the 193 ancestors have a recall of any class.
  • Of its descendants, K124061 (Invivo Corporation, 2013) has gone furthest, with 4 descendants of its own.
  • 2 other devices also cite its predicate K053462.

How does its category compare?

All MWI devices

MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MWI

4in 2025

2007: 92008: 92009: 62010: 172011: 112012: 132013: 202014: 162015: 192016: 122017: 132018: 112019: 142020: 82021: 92022: 52023: 82024: 102025: 42026 (partial year): 6
2007high 20 (2013) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MWI

247in 2025

2007: 42 days median2008: 49 days median2009: 112 days median2010: 58 days median2011: 78 days median2012: 104 days median2013: 85 days median2014: 148 days median2015: 127 days median2016: 165 days median2017: 205 days median2018: 217 days median2019: 255 days median2020: 138 days median2021: 161 days median2022: 231 days median2023: 250 days median2024: 202 days median2025: 247 days median2026 (partial year): 239 days median
2007high 255 (2019) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MWI

9so far in 2026, the most since 2007

2007: 12008: 12009: 22010: 22011: 32012: 52013: 32014: 62015: 12017: 22019: 42022: 22024: 52026 (partial year): 9
2007high 9 (2026) · low 0 (2016)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MWI

182in 2025

2007: 32008: 32009: 202010: 172011: 162012: 312013: 422014: 302015: 312016: 512017: 852018: 1582019: 1692020: 1102021: 1882022: 1682023: 1792024: 1202025: 182
2007high 188 (2021) · low 3 (2007)2025

MAUDE reports naming product code MWI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200794213
200894913
20096112220
20101758217
20111178316
201213104531
20132085342
201416148630
201519127131
201612165051
201713205285
2018112170158
2019142554169
202081380110
202191610188
202252312168
202382500179
2024102025120
202542470182
202662399—

What is it indicated for?

The MRI Patient Monitoring System (Model 865214) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.

The MRI Patient Monitoring System (Model 865214) is intended for use by healthcare professionals.

Indications for use as stated in the FDA summary.

Also cleared against K053462

2 other devices cite the same predicate.

  • K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007
  • K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007

More from Invivo Corp.

4 FDA decisions under this applicant name. See the company

  • K052704Model BBD Breast Immobilization and Biopsy DeviceInvivo Corp. · 2005
  • K052497Neurovascular Array Coil, Model Nva-127-16-aInvivo Corp. · 2005
  • K051512Cac-127-8 Cardoac Array CoilInvivo Corp. · 2005

Recent decisions in MWI

The MWI category page

  • K260801Sensinel Cardiopulmonary Management (CPM) SystemAnalog Devices · 2026
  • K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc. · 2026
  • K253417Masimo Root Monitoring SystemMasimo Corporation · 2026
  • K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation · 2026
  • K253436c-med0 alphaCosinuss GmbH · 2026

https://510kreport.com/device/K090785 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090785: Mri Compatible Patient Monitoring System, Model 865214.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090785

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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