510(k) · Cleared
Recalled · Class II · 2018B40i Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare Finland Oy · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jul 31, 2015 as substantially equivalent to K133576 (Ge Medical Systems China Co., Ltd., 2014) and 2 other predicates after a 219-day review. Its family tree reaches back 10 generations to 1997. 5 of the 78 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled once.
- Decided
- Jul 31, 2015
- Review
- 219 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 10 generations to K962603 (1997). 73 ancestors in all, the oldest K896030 (1989). 4 later devices descend from it, 1 citing it directly. 5 of the 78 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations between
- 3 generations backK120598 Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · Recalled
- 2 generations backK130584 Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · Recalled
- 1 generation backK133576 Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · Recalled (Class I)
- This deviceK143676 B40i Patient MonitorGE Healthcare Finland Oy · 2015
- Descendant · cites it directly · 3 of its ownK201941 Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK213490 Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor…Ge Medical Systems Information Technologies, Inc. · 2022 · Recalled
- Descendant · 3 generations on · 0 of its ownK242562 Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor…Ge Medical Systems Information Technologies, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK233810 Portrait VSMGe Medical Systems Information Technologies, Inc. · 2024 · Recalled
Show all 10 generations
- Root · 10 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 9 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 8 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 7 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 6 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 5 generations backK022193 Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400NGe Medical Systems Information Technologies · 2002
- 4 generations backK073203 Carescape V100Ge Medical Systems Information Technologies · 2007
- 3 generations backK120598 Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · Recalled
- 2 generations backK130584 Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · Recalled
- 1 generation backK133576 Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · Recalled (Class I)
- This deviceK143676 B40i Patient MonitorGE Healthcare Finland Oy · 2015
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc. · 2020 · cites it directly3descendants
- K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc. · 2022 · 2 generations on2descendants
- K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc. · 2025 · 3 generations on0descendants
- K233810Portrait VSMGe Medical Systems Information Technologies, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −9 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −8 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −7 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −6 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −5 | K022193 | Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400N | Ge Medical Systems Information Technologies | 2002 | — |
| −4 | K073203 | Carescape V100 | Ge Medical Systems Information Technologies | 2007 | — |
| −3 | K120598 | Procare Monitor B40 | Ge Medical Systems China Co., Ltd. | 2012 | 2 |
| −2 | K130584 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2013 | 2 |
| −1 | K133576 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2014 | Class I |
| 0 (this device) | K143676 | B40i Patient Monitor | GE Healthcare Finland Oy | 2015 | — |
| +1 | K201941 | Monitor B125, Monitor B105 | Ge Medical Systems Information Technologies, Inc. | 2020 | — |
| +2 | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2022 | 6 |
| +3 | K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2025 | — |
| +3 | K233810 | Portrait VSM | Ge Medical Systems Information Technologies, Inc. | 2024 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 8 | 0 |
| 2001 | 3 | 0 |
| 2002 | 8 | 1 |
| 2003 | 4 | 0 |
| 2004 | 5 | 2 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 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.
5 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? (3)
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 |
|---|---|---|---|
| * | K133576 | Monitor B40Summary page 5…odes BZQ CBQ CBR CBS CCK CCL DQA DRT DSB DSK DXN FLL GWQ NHO NHP NHQ Predicate Device(s) (807.92(a)(3): K133576 Monitor B40 K071073 Patient Data Module Device Description The proposed monitor B40i is a multi-pa… | 2014 |
| * | K071073 | Solar 8000 and Transport Pro with Patient Data ModuleSummary page 5…CCL DQA DRT DSB DSK DXN FLL GWQ NHO NHP NHQ Predicate Device(s) (807.92(a)(3): K133576 Monitor B40 K071073 Patient Data Module Device Description The proposed monitor B40i is a multi-parameter patient monitor (807.92(a)(4)… | 2007 |
| * | K042642 | Aware Transport Monitor System (Includes Aware Pod and Aware Transport Monitor)Summary page 5…impedance respiration implementation especially concerning the algorithm used is based on the predicate Aware Transport (K042642). The proposed monitor B40i utilizes 12 inch LCD display panel and LED backlight with an integrated… | 2004 |
| † | K061907 | Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and Accessories | 2008 |
| † | K123195 | Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and Accessories | 2013 |
| † | K052582 | Datex-Ohmeda S/5 Single-Width Airway Module, E-Minic and Accessories | 2005 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201941 | Monitor B125, Monitor B105 | 2020 | 3 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 11, 2018 | Class II | Z-0586-2019 | Software design | Patient monitors may restart due to network overload caused by network configuration. |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K123195Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and AccessoriesGE Healthcare Finland Oy · 2013 · 3 generations back · ◆ in the 2013 ancestors bar of FIG. 13 Class I recalls
- K043276Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec ModuleDatex-Ohmeda · 2004 · 4 generations back · ◆ in the 2004 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
- 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
What does this lineage say?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 24 of the 73 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K201941 (Ge Medical Systems Information Technologies, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K133576.
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. 2015, 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 B40i is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The B40i is intended for use under the direct supervision of a licensed health care practitioner. The B40i is not intended for use during MRI. The B40i can be a stand-alone monitor or interfaced to…
Read the full statement (156 words)
The B40i is a portable multi-parameter unit to be used for monitoring and recording of,
and to generate alarms for, multiple physiological parameters of adult, pediatric, and
neonatal patients in a hospital environment and during intra-hospital transport.
The B40i is intended for use under the direct supervision of a licensed health care
practitioner.
The B40i is not intended for use during MRI.
The B40i can be a stand-alone monitor or interfaced to other devices via a network.
The B40i monitors and displays: ECG (including ST segment, arrhythmia detection),
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) and Entropy.
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/K143676 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143676: B40i Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143676
Report an extraction error
Are you the manufacturer?
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