510(k) · Cleared
Recalled · Class II · 2025Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Apr 1, 2022 as substantially equivalent to K201941 (Ge Medical Systems Information Technologies, Inc., 2020) and 3 other predicates after a 151-day review. Its family tree reaches back 34 generations to 1994. 7 of the 393 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 6 times.
- Decided
- Apr 1, 2022
- Review
- 151 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 6
- Predicates
- 4
Its longest line of descent runs back 34 generations to K941811 (1994). 390 ancestors in all, the oldest K820885 (1982). 2 later devices descend from it, 2 citing it directly. 7 of the 393 devices in this family, counting this one, have a Class I recall.
- Root · 34 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 30 generations between
- 3 generations backK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
- 2 generations backK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
- 1 generation backK201941 Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc. · 2020
- This deviceK213490 Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor…Ge Medical Systems Information Technologies, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK242562 Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor…Ge Medical Systems Information Technologies, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK233810 Portrait VSMGe Medical Systems Information Technologies, Inc. · 2024 · Recalled
Show all 34 generations
- Root · 34 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 33 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 32 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 31 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 30 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 29 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 28 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 27 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 26 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 25 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 24 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 23 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 22 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
- 21 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- 20 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- 19 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- 18 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 17 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 16 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- 15 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- 14 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 13 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- 12 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- 11 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 10 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
- 9 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- 8 generations backK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
- 7 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
- 6 generations backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- 5 generations backK101449 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- 4 generations backK110622 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
- 3 generations backK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
- 2 generations backK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
- 1 generation backK201941 Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc. · 2020
- This deviceK213490 Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor…Ge Medical Systems Information Technologies, Inc. · 2022
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −34 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −33 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −32 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −31 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −30 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −29 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −28 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −27 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −26 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −25 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −24 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −23 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −22 | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −21 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −20 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| −19 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −18 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −17 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −16 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −15 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −14 | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −13 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| −12 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
| −11 | K061610 | Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −10 | K063315 | Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −9 | K071426 | MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
| −8 | K083517 | Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | 2 |
| −7 | K091927 | Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | — |
| −6 | K100939 | Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| −5 | K101449 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| −4 | K110622 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | 2 |
| −3 | K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | — |
| −2 | K122223 | New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp… | Philips Medizin Systeme Boeblingen GmbH | 2013 | — |
| −1 | K201941 | Monitor B125, Monitor B105 | Ge Medical Systems Information Technologies, Inc. | 2020 | — |
| 0 (this device) | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2022 | — |
| +1 | K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2025 | — |
| +1 | K233810 | Portrait VSM | Ge Medical Systems Information Technologies, Inc. | 2024 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 3 | 0 |
| 1989 | 6 | 0 |
| 1990 | 8 | 0 |
| 1991 | 15 | 0 |
| 1992 | 9 | 0 |
| 1993 | 8 | 0 |
| 1994 | 5 | 0 |
| 1995 | 11 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 1 |
| 1998 | 22 | 0 |
| 1999 | 19 | 0 |
| 2000 | 31 | 0 |
| 2001 | 14 | 0 |
| 2002 | 27 | 1 |
| 2003 | 21 | 1 |
| 2004 | 27 | 2 |
| 2005 | 18 | 0 |
| 2006 | 17 | 0 |
| 2007 | 10 | 0 |
| 2008 | 5 | 0 |
| 2009 | 11 | 0 |
| 2010 | 12 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 1 |
| 2014 | 3 | 1 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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.
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 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? (4)
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 |
|---|---|---|---|
| * | K201941 | Monitor B125, Monitor B105Summary page 6…Code: DSK, GWQ, FLL, NHO, NHP, NHQ, DPZ, DQK, DSI, DSJ, KRB, MLD, OLT, OLW, OMC, ORT, KOI Predicate Device(s) Primary Predicate: K201941 Monitor B125/B105 (807.92(a)(3)): Additional Predicate Devices: K1… | 2020 |
| * | K191249 | Carescape B450Summary page 6…ate Device(s) Primary Predicate: K201941 Monitor B125/B105 (807.92(a)(3)): Additional Predicate Devices: K191249 CARESCAPE B450 K133810 CARESCAPE VC150 K200494 CARESCAPE ONE Device D… | 2020 |
| * | K133810 | VC150 Vital Signs MonitorSummary page 6…B125/B105 (807.92(a)(3)): Additional Predicate Devices: K191249 CARESCAPE B450 K133810 CARESCAPE VC150 K200494 CARESCAPE ONE Device Description The proposed monitors B105M, B125M,… | 2014 |
| * | K200494 | CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESSummary page 6…Additional Predicate Devices: K191249 CARESCAPE B450 K133810 CARESCAPE VC150 K200494 CARESCAPE ONE Device Description The proposed monitors B105M, B125M, B155M, B105P and (807.92(a)(4)): B125P a… | 2020 |
| † | K051635 | Datex-Ohmeda S/5 Neuromuscular Transmission Module, E-NMT and Accessories | 2005 |
| † | K032582 | Unity Network Patient Data Server | 2003 |
| † | K052582 | Datex-Ohmeda S/5 Single-Width Airway Module, E-Minic and Accessories | 2005 |
| † | K171028 | CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and… | 2017 |
| † | K151063 | Monitor B40 | 2015 |
| † | K150298 | Entropy Module, E-ENTROPY-01 | 2015 |
| † | K052976 | Datex-Ohmeda S/5 Cardiac Output Module, E-Cop and Accessories | 2006 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 26, 2025 | Class II | Z-0455-2026 | Component change control | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and… |
| Nov 16, 2022 | Class II | Z-0733-2023 | Device Design | GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near… |
| Nov 16, 2022 | Class II | Z-0729-2023 | Device Design | GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near… |
| Nov 16, 2022 | Class II | Z-0730-2023 | Device Design | GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near… |
| Nov 16, 2022 | Class II | Z-0732-2023 | Device Design | GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near… |
| Nov 16, 2022 | Class II | Z-0731-2023 | Device Design | GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near… |
The 5 latest of 6 recalls; the web page lists all.
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 · 3 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 · 4 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 · 5 generations back · ◆ in the 2013 ancestors bar of FIG. 13 Class I recalls
- K031187Heartstart MRX, Model M3535APhilips Medical Systems · 2003 · 5 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 · 5 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 · 6 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 7 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 28 years and passes through 9 companies; a new generation was cleared every 4 months on median.
- 84 of the 390 ancestors have a recall of any class; 7 have a Class I recall.
- Of its descendants, K242562 (Ge Medical Systems Information Technologies, Inc., 2025) has gone furthest, with 0 descendants of its own.
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. 2022, 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?
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 (251 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 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, 02, N20, anesthetic agents, anesthetic agent identification and respiratory rate), Cardiac Output (C.O.), Entropy and neuromuscular transmission (NMT).
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213490 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213490: 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/K213490
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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