510(k) Report

510(k) · Cleared

Cleared

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P

K242562510(k) TraditionalCleared Jul 9, 2025315-day reviewClass II21 CFR 870.1025

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

Ge Medical Systems Information Technologies, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Jul 9, 2025 as substantially equivalent to K213490 (Ge Medical Systems Information Technologies, Inc., 2022) and 1 other predicate after a 315-day review. Its family tree reaches back 35 generations to 1994. 7 of the 393 devices in its family, counting itself, have a Class I recall.

Decided
Jul 9, 2025
Review
315 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
2

Its longest line of descent runs back 35 generations to K941811 (1994). 392 ancestors in all, the oldest K820885 (1982). No later device cites it as a predicate yet. 7 of the 393 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year cleared 2022: 1 other ancestor2020: 3 other ancestors2014: 3 other ancestors, 1 with a Class I recall12019: 1 other ancestor2017: 1 other ancestor2016: 1 other ancestor2015: 2 other ancestors2013: 5 other ancestors, 1 with a Class I recall12012: 5 other ancestors2011: 3 other ancestors2010: 12 other ancestors2009: 11 other ancestors2008: 5 other ancestors2007: 10 other ancestors2006: 17 other ancestors2005: 18 other ancestors2004: 27 other ancestors, 2 with a Class I recall22001: 14 other ancestors1984: 2 other ancestors2003: 21 other ancestors, 1 with a Class I recall12002: 27 other ancestors, 1 with a Class I recall12000: 31 other ancestors1999: 19 other ancestors1998: 22 other ancestors1997: 13 other ancestors, 1 with a Class I recall11996: 12 other ancestors1993: 8 other ancestors1992: 9 other ancestors1991: 15 other ancestors1990: 8 other ancestors1989: 6 other ancestors1987: 3 other ancestors1986: 2 other ancestors1985: 2 other ancestors1982: 2 other ancestors1995: 11 other ancestors1994: 5 other ancestorsReference device: K052145 · Datex-Ohmeda S/5 Bis Module, E-Bis and Accessories · GE Healthcare · 2005Reference device: K072286 · Bis Eeg Vista Monitor System and Bisx · Aspect Medical Systems, Inc. · 2007 · recalledReference device: K052582 · Datex-Ohmeda S/5 Single-Width Airway Module, E-Minic and Accessories · GE Healthcare · 2005 · Class I recallReference device: K171028 · CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories · GE Healthcare Finland Oy · 2017 · Class I recallReference device: K151063 · Monitor B40 · Ge Medical Systems China Co., Ltd. · 2015 · recalledReference device: K150298 · Entropy Module, E-ENTROPY-01 · Ge Healthcare Filand OY · 2015Reference device: K052976 · Datex-Ohmeda S/5 Cardiac Output Module, E-Cop and Accessories · GE Healthcare · 2006Reference device: K051635 · Datex-Ohmeda S/5 Neuromuscular Transmission Module, E-NMT and Accessories · GE Healthcare · 2005 · recalledK941811 · 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) K071426 · MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient Monitors · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007K083517 · Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · recalledK091927 · Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009×2: 2 generations cleared close together, K100939 (2010), K101449 (2010) K110622 · Intellivue Patient Monitor · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · recalledK111905 · Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011K122223 · New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO · Philips Medizin Systeme Boeblingen GmbH · 2013K201941 · Monitor B125, Monitor B105 · Ge Medical Systems Information Technologies, Inc. · 2020K213490 · Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P · Ge Medical Systems Information Technologies, Inc. · 2022 · recalled19801990200020102020
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 13 other ancestors4 generations back: 28 other ancestors, 1 with a Class I recall15 generations back: 44 other ancestors, 1 with a Class I recall16 generations back: 84 other ancestors, 3 with a Class I recall37 generations back: 83 other ancestors, 1 with a Class I recall18 generations back: 47 other ancestors, 1 with a Class I recall19 generations back: 30 other ancestors10 generations back: 15 other ancestors11 generations back: 8 other ancestors12 generations back: 1 other ancestor K213490 · Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P · Ge Medical Systems Information Technologies, Inc. · 2022 · recalledK201941 · Monitor B125, Monitor B105 · Ge Medical Systems Information Technologies, Inc. · 2020K122223 · New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO · Philips Medizin Systeme Boeblingen GmbH · 2013K111905 · Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011K110622 · Intellivue Patient Monitor · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · recalledK101449 · Intellivue Patient Monitor · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010K100939 · Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 and MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010K091927 · Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009K083517 · Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · recalledK071426 · 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. · 1994−35−30−25−20−15−10−50
  1. Root · 35 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 31 generations between
  3. 3 generations backK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
  4. 2 generations backK201941 Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc. · 2020
  5. 1 generation backK213490 Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor…Ge Medical Systems Information Technologies, Inc. · 2022 · Recalled
  6. This deviceK242562 Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor…Ge Medical Systems Information Technologies, Inc. · 2025
Show all 35 generations
  1. Root · 35 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 34 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 33 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 32 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 31 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 30 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 29 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 28 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 27 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 26 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 25 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 24 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 23 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 22 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 21 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 20 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 19 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 18 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 17 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 16 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 15 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  22. 14 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  23. 13 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
  24. 12 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  25. 11 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
  26. 10 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  27. 9 generations backK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
  28. 8 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
  29. 7 generations backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  30. 6 generations backK101449 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  31. 5 generations backK110622 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
  32. 4 generations backK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
  33. 3 generations backK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
  34. 2 generations backK201941 Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc. · 2020
  35. 1 generation backK213490 Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor…Ge Medical Systems Information Technologies, Inc. · 2022 · Recalled
  36. This deviceK242562 Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor…Ge Medical Systems Information Technologies, Inc. · 2025

Class I recalls in this family

  • K133576 Monitor B404 generations back · 2014
  • K040831 Datex-Ohmeda Trusat Pulse Oximeter and…5 generations back · 2004
  • K123195 Carescape Respiratory Modules, E-Sco, E-Scov…6 generations back · 2013
  • K031187 Heartstart MRX, Model M3535A6 generations back · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−35K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−34K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−33K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−32K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−31K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−30K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−29K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−28K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−27K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−26K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−25K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−24K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−23K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−22K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−21K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−20K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−19K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−18K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−17K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−16K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−15K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−14K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
−13K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—
−12K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−11K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80…Philips Medizin Systeme Boeblingen GmbH2006—
−10K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
−9K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20092
−8K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009—
−7K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
−6K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
−5K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20112
−4K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011—
−3K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp…Philips Medizin Systeme Boeblingen GmbH2013—
−2K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.2020—
−1K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.20226
0 (this device)K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198220
198420
198520
198620
198730
198960
199080
1991150
199290
199380
199450
1995110
1996120
1997131
1998220
1999190
2000310
2001140
2002271
2003211
2004272
2005180
2006170
2007100
200850
2009110
2010120
201130
201250
201351
201431
201520
201610
201710
201910
202030
202210
FIG. 1 — Lineage of K242562, 1994–2025Source: 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.

7 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. #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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
*K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
Summary page 7
…Code: DQK, DSI, DSJ, DSK, GWQ, FLL, NHO, NHP, NHQ, KRB, MLD, OLT, OLW, OMC, ORT, KOI Predicate Device(s) Primary Predicate: K213490 Monitors B105M, B125M, B155M, (807.92(a)(3)): B105P and B125P Additional Predicate Devices…
Ge Medical Systems Information Technologies, Inc.20226
*K213363CARESCAPE B450, E-musb
Summary page 7
…5M, B125M, B155M, (807.92(a)(3)): B105P and B125P Additional Predicate Devices: CARESCAPE Monitor B450 (K213363) Device Description The proposed monitors B105M, B125M, B155M, B105P and (807.92(a)(4)): B125P are new versi…
GE Healthcare Finland Oy20221
†K052145Datex-Ohmeda S/5 Bis Module, E-Bis and AccessoriesGE Healthcare2005—
†K072286Bis Eeg Vista Monitor System and BisxAspect Medical Systems, Inc.20071
†K052582Datex-Ohmeda S/5 Single-Width Airway Module, E-Minic and AccessoriesGE Healthcare2005Class I
†K171028CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and…GE Healthcare Finland Oy2017Class I
†K151063Monitor B40Ge Medical Systems China Co., Ltd.20151
†K150298Entropy Module, E-ENTROPY-01Ge Healthcare Filand OY2015—
†K052976Datex-Ohmeda S/5 Cardiac Output Module, E-Cop and AccessoriesGE Healthcare2006—
†K051635Datex-Ohmeda S/5 Neuromuscular Transmission Module, E-NMT and AccessoriesGE Healthcare20051

Also cleared against K213490: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (7 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.

  • K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 4 generations back · ◆ in the 2014 ancestors bar of FIG. 11 Class I recall
  • K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 2004 · 5 generations back · ◆ in the 2004 ancestors bar of FIG. 13 Class I recalls
  • K123195Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and AccessoriesGE Healthcare Finland Oy · 2013 · 6 generations back · ◆ in the 2013 ancestors bar of FIG. 13 Class I recalls
  • K031187Heartstart MRX, Model M3535APhilips Medical Systems · 2003 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 12 Class I recalls
  • K021955Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters & AccessoriesDatex-Ohmeda, Inc. · 2002 · 6 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
  • K043276Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec ModuleDatex-Ohmeda · 2004 · 7 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
  • K970209Capnocheck PlusBci Intl., Inc. · 1997 · 8 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall

Nearest 5 of 7; all are on the web page.

What does this lineage say?

  • The line of descent spans 31 years and passes through 9 companies; a new generation was cleared every 4 months on median.
  • 86 of the 392 ancestors have a recall of any class; 7 have a Class I recall.
  • 1 other device also cites its predicate K213490.

How does its category compare?

All MHX devices

MHX 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

2007: 152008: 162009: 132010: 202011: 122012: 162013: 212014: 132015: 142016: 132017: 142018: 112019: 72020: 112021: 52022: 152023: 82024: 52025: 82026 (partial year): 14
2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007: 96 days median2008: 58 days median2009: 57 days median2010: 90 days median2011: 81 days median2012: 88 days median2013: 120 days median2014: 248 days median2015: 203 days median2016: 149 days median2017: 134 days median2018: 203 days median2019: 243 days median2020: 196 days median2021: 195 days median2022: 189 days median2023: 229 days median2024: 181 days median2025: 192 days median2026 (partial year): 205 days median
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

2007: 32008: 22009: 72010: 132011: 162012: 112013: 142014: 62015: 52016: 72017: 62018: 122019: 62022: 62023: 32024: 32025: 152026 (partial year): 21
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

2007: 1312008: 2322009: 3822010: 9552011: 9492012: 6762013: 1,9972014: 1,6092015: 1,2842016: 1,1052017: 1,1152018: 2,1572019: 1,4622020: 1,7142021: 2,4232022: 1,4702023: 2,2542024: 2,8142025: 3,761
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200715963131
200816582232
200913577382
2010209013955
2011128116949
2012168811676
201321120141,997
20141324861,609
20151420351,284
20161314971,105
20171413461,115
201811203122,157
2019724361,462
20201119601,714
2021519502,423
20221518961,470
2023822932,254
2024518132,814
20258192153,761
20261420521—

What is it indicated for?

The monitor B105M, B125M, B155M, B105P and B125P are portable multi-parameter patient monitors intended to be used for monitoring, recording, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The monitor B105M, B125M, B155M, B105P and B125P are intended for use under the direct supervision of a licensed health care practitioner. The…

Read the full statement (292 words)

The monitor B105M, B125M, B155M, B105P and B125P are portable multi-parameter patient monitors intended to be used for monitoring, recording, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

The monitor B105M, B125M, B155M, B105P and B125P are intended for use under the direct supervision of a licensed health care practitioner.

The monitor B105M, B125M, B155M, B105P and B125P are not Apnea monitors (i.e., do not rely on the device for detection or alarm for the cessation of breathing). These devices should not be used for life sustaining/supporting purposes.

The monitor B105M, B125M, B155M, B105P and B125P are not intended for use during MRI.

The monitor B105M, B125M, B155M, B105P and B125P can be stand-alone monitors or interfaced to other devices via network.

The monitor B105M, B125M, B155M, B105P and B125P monitor and display: ECG (including ST segment, arrhythmia detection, ECG diagnostic analysis and measurement), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate), Cardiac Output (C.O.), Entropy, neuromuscular transmission (NMT) and Bispectral Index (BIS).

The monitor B105M, B125M, B155M, B105P and B125P are able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Rhythm, Ventricular Couplet, Bigeminy, Trigeminy, “R on T”, Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Irregular, Multifocal PVCs, Missing Beat, SV Tachy, Premature Ventricular Contraction (PVC), Supra Ventricular Contraction (SVC) and Ventricular fibrillation.

Indications for use as stated in the FDA summary.

Also cleared against K213490

1 other device cites the same predicate.

  • K233810Portrait VSMGe Medical Systems Information Technologies, Inc. · 20241 recall

More from Ge Medical Systems Information…

32 FDA decisions under this applicant name. See the company

  • K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc. · 2026
  • K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2026
  • K243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)Ge Medical Systems Information Technologies, Inc. · 2024
  • K233810Portrait VSMGe Medical Systems Information Technologies, Inc. · 20241 recall
  • K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) •…Ge Medical Systems Information Technologies, Inc. · 20244 recalls

Recent decisions in MHX

The MHX category page

  • K260676Radius VSM and AccessoriesMasimo Corporation · 2026
  • K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM…GE Healthcare Finland Oy · 2026
  • K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy · 2026
  • K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc. · 2026
  • K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc. · 2026

https://510kreport.com/device/K242562 · printed Nov 6, 2026

Cite this page

510(k) Report. “K242562: Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242562

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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