510(k) · Cleared
ClearedVista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Draeger Medical Instrument Co., Ltd. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Apr 10, 2026 as substantially equivalent to K232962 (Edan Instruments, Inc., 2024) after a 267-day review. Its family tree reaches back 35 generations to 1994. 1 of the 232 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 10, 2026
- Review
- 267 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 35 generations to K941811 (1994). 231 ancestors in all, the oldest K844187 (1985). No later device cites it as a predicate yet. 1 of the 232 devices in this family, counting this one, has a Class I recall.
- Root · 35 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 31 generations between
- 3 generations backK192514 Patient MonitorEdan Instruments, Inc. · 2020 · Recalled
- 2 generations backK202336 Patient MonitorEdan Instruments, Inc. · 2021 · Recalled
- 1 generation backK232962 Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc. · 2024 · Recalled
- This deviceK252250 Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064)…Shanghai Draeger Medical Instrument Co., Ltd. · 2026
Show all 35 generations
- Root · 35 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 34 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 33 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 32 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 31 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 30 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 29 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 28 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 27 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 26 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 25 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 24 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 23 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
- 22 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- 21 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- 20 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- 19 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 18 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 17 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- 16 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- 15 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 14 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- 13 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- 12 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 11 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
- 10 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- 9 generations backK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
- 8 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
- 7 generations backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- 6 generations backK113623 Patient MonitorEdan Instruments, Inc. · 2012 · Recalled
- 5 generations backK131971 IM60/IM70 Patient MonitorEdan Instruments, Inc. · 2014 · Recalled
- 4 generations backK160981 Patient MonitorEdan Instruments, Inc. · 2016 · Recalled
- 3 generations backK192514 Patient MonitorEdan Instruments, Inc. · 2020 · Recalled
- 2 generations backK202336 Patient MonitorEdan Instruments, Inc. · 2021 · Recalled
- 1 generation backK232962 Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc. · 2024 · Recalled
- This deviceK252250 Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064)…Shanghai Draeger Medical Instrument Co., Ltd. · 2026
Class I recalls in this family
- K970209 Capnocheck Plus10 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −35 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −34 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −33 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −32 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −31 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −30 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −29 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −28 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −27 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −26 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −25 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −24 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −23 | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −22 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −21 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| −20 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −19 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −18 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −17 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −16 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −15 | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −14 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| −13 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
| −12 | K061610 | Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −11 | K063315 | Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −10 | K071426 | MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
| −9 | K083517 | Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | 2 |
| −8 | K091927 | Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | — |
| −7 | K100939 | Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| −6 | K113623 | Patient Monitor | Edan Instruments, Inc. | 2012 | 2 |
| −5 | K131971 | IM60/IM70 Patient Monitor | Edan Instruments, Inc. | 2014 | 2 |
| −4 | K160981 | Patient Monitor | Edan Instruments, Inc. | 2016 | 1 |
| −3 | K192514 | Patient Monitor | Edan Instruments, Inc. | 2020 | 1 |
| −2 | K202336 | Patient Monitor | Edan Instruments, Inc. | 2021 | 1 |
| −1 | K232962 | Patient Monitor (iX10, iX12, iX15) | Edan Instruments, Inc. | 2024 | 1 |
| 0 (this device) | K252250 | Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300… | Shanghai Draeger Medical Instrument Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 3 | 0 |
| 1990 | 7 | 0 |
| 1991 | 8 | 0 |
| 1992 | 8 | 0 |
| 1993 | 8 | 0 |
| 1994 | 3 | 0 |
| 1995 | 10 | 0 |
| 1996 | 11 | 0 |
| 1997 | 9 | 1 |
| 1998 | 18 | 0 |
| 1999 | 12 | 0 |
| 2000 | 21 | 0 |
| 2001 | 9 | 0 |
| 2002 | 15 | 0 |
| 2003 | 14 | 0 |
| 2004 | 17 | 0 |
| 2005 | 6 | 0 |
| 2006 | 6 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 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.
1 device in this family has 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? (1)
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 |
|---|---|---|---|
| * | K232962 | Patient Monitor (iX10, iX12, iX15)Summary page 6…Burst suppression detection software for ORT electroencephalograph Predicate Device: Patient Monitor, Model: iX10, iX12, iX15, K232962 Reference Devices: Dräger Infinity Acute Care System (IACS) Monitoring System, K203088… | 2024 |
| † | K203088 | Infinity Acute Care System (IACS) Monitoring System | 2022 |
| † | K221118 | CO2 Mainstream Sensor | 2023 |
| † | K150272 | Capnostream 35 Portable Respiratory Monitor | 2015 |
| † | K213911 | Microstream CO2 NanoPod | 2022 |
| † | K040183 | BISX | 2004 |
| † | K052981 | Bis Eeg Monitor, Model BISX4 | 2005 |
| † | K172690 | ToFscan | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 10 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 10 companies; a new generation was cleared every 4 months on median.
- 38 of the 231 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K232962.
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. 2026, 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?
Vista 300: The monitors are intended to be used for monitoring, storing, recording and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR)…
Read the full statement (236 words)
Vista 300:
The monitors are intended to be used for monitoring, storing, recording and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments.
The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic Gas (AG), bispectral index (BIS), neuromuscular transmission (NMT).
The monitors are not intended for MRI environments.
Vista 300 S:
The monitors are intended to be used for monitoring, storing, recording and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments.
The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.) (for adults only), anesthetic Gas (AG).
The monitors are not intended for MRI environments.
For Vista 300/Vista 300 S:
The arrhythmia detection and ST Segment analysis are intended for adult patients.
The NIBP monitoring supports iCUFS algorithm. The iCUFS algorithm is intended for adult, pediatric and neonatal patients. It is also intended for use with pregnant women, including pre-eclamptic patients. NIBP MAP is not applicable to pregnant women.
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/K252250 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252250: Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252250
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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