510(k) · Cleared
ClearedPM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jun 26, 2007 as substantially equivalent to K053234 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2006) and 4 other predicates after a 96-day review. Its family tree reaches back 12 generations to 1994. 47 later devices descend from it.
- Decided
- Jun 26, 2007
- Review
- 96 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K941811 (1994). 88 ancestors in all, the oldest K842616 (1984). 47 later devices descend from it, 6 citing it directly.
- Root · 12 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 8 generations between
- 3 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 2 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 1 generation backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- This deviceK070791 PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- Descendant · cites it directly · 19 of its ownK072581 PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- Descendant · cites it directly · 19 of its ownK072346 PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- Descendant · 2 generations on · 16 of its ownK100046 M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd. · 2010
- Descendant · 2 generations on · 9 of its ownK090599 MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2009
- Descendant · 3 generations on · 8 of its ownK152563 Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd. · 2016
Show all 12 generations
- Root · 12 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 11 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 10 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 9 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 8 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 7 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 6 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 5 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 4 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 3 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 2 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 1 generation backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- This deviceK070791 PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · cites it directly19descendants
- K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · cites it directly19descendants
- K100046M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd. · 2010 · 2 generations on16descendants
- K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2009 · 2 generations on9descendants
- K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd. · 2016 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −11 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −10 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −9 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −8 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −7 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −6 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −5 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −4 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −3 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −2 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −1 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| 0 (this device) | K070791 | PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| +1 | K072581 | PM-60 Pulse Oximeter | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| +1 | K072346 | PM-7000 Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| +2 | K100046 | M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000 | Guangdong Biolight Meditech Co., Ltd. | 2010 | — |
| +2 | K090599 | MD300K1 Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2009 | — |
| +3 | K152563 | Pulse Oximeter (MD300M/MD300K2) | Beijing Choice Electronic Technology Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 4 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 4 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 13 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
Planning a device in MHX? 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? (5)
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 |
|---|---|---|---|
| * | K053234 | PM-9000 Express Patient MonitorSummary page 2…lass [L 21 CFR 868.1720 Oxygen gas analyzer Class I[ Legally Marketed Predicate Devices: I) K#053234, PM-9000 Express Patient Monitor, SHENZHEN MINDRAY 1310-MEDICAL ELECTRONICS CO., LTD.… | 2006 |
| * | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O.Summary page 2…I) K#053234, PM-9000 Express Patient Monitor, SHENZHEN MINDRAY 1310-MEDICAL ELECTRONICS CO., LTD. 2) K#032858, IntelliVue MP60 and MP70 Patient Monitors, Philips Co., Ltd. 3) K#012467, SOLAR 8000M SYST… | 2003 |
| * | K012467 | Solar 8000M SystemSummary page 2…MINDRAY 1310-MEDICAL ELECTRONICS CO., LTD. 2) K#032858, IntelliVue MP60 and MP70 Patient Monitors, Philips Co., Ltd. 3) K#012467, SOLAR 8000M SYSTEM, GENERAL ELECTRIC MEDICAL. SYSTEMS INFORMATION TECH. 4)… | 2002 |
| * | K020550 | Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXSummary page 2…Co., Ltd. 3) K#012467, SOLAR 8000M SYSTEM, GENERAL ELECTRIC MEDICAL. SYSTEMS INFORMATION TECH. 4) K#020550, Passport 2 Vital Signs Monitor with View 12 ECG Analysis Module, Datascope Corp. 5) K#053193,… | 2002 |
| * | K053193 | PM-8000 Express Patient Monitor, Model PM-8000 ExpressSummary page 2…STEMS INFORMATION TECH. 4) K#020550, Passport 2 Vital Signs Monitor with View 12 ECG Analysis Module, Datascope Corp. 5) K#053193, PM-8000 EXPRESS PATIENT MONITOR, SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Description:… | 2006 |
What descends from it? (47)
See all 476 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072581 | PM-60 Pulse Oximeter | 2008 | 19 |
| K072346 | PM-7000 Patient Monitor | 2007 | 19 |
| K073280 | Beneview T Series Patient Monitors, Models T8, T6 and T5 | 2008 | 2 |
| K112877 | Comen Multi-Parameter Patient Monitor | 2012 | 1 |
| K091834 | Passport V Monitor, Model 0998-00-6100 | 2009 | 0 |
| K082887 | PM-1000F+Patient Monitor | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 6 companies; a new generation was cleared every 4 months on median.
- 10 of the 88 ancestors have a recall of any class.
- Of its descendants, K072581 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2008) has gone furthest, with 19 descendants of its own.
- 5 other devices also cite its predicate K053234.
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. 2007, 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 PM Series Patient Monitors including-models PM-9000 Express and PM-8000 Express are intended to be used for monitoring, recording, and alarming of multiple physiological parameters in health care facilities by qualified health care professionals trained in the use of the equipment. The physiological parameters that can be monitored by PM-9000 Express Patient Monitor are: ECG(3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST Segment…
Read the full statement (218 words)
The PM Series Patient Monitors including-models PM-9000 Express and PM-8000 Express are intended to be used for monitoring, recording, and alarming of multiple physiological parameters in health care facilities by qualified health care professionals trained in the use of the equipment.
The physiological parameters that can be monitored by PM-9000 Express Patient Monitor are: ECG(3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST Segment analysis, Heart Rate(HR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Pulse Oxygen Saturation (SpO2), Temperature (TEMP), Invasive Blood Pressure(IBP), Pulse Rate(PR), Carbon Dioxide (CO2), and Anaesthetic Gases(AG).
The physiological parameters that can be monitored by PM-8000 Express Patient Monitor are: ECG(3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, Heart Rate(HR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Pulse Oxygen Saturation (SpO2), Temperature (TEMP), Invasive Blood Pressure(IBP) and Pulse Rate(PR) , and Carbon Dioxide (CO2).
Their design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs.
The target populations are human patients ranged from adult to neonate with the exception of the arrhythmia detection and ST Segment analysis, for which the target populations are adult and pediatric only.
The PM Series Patient Monitors are not intended for use in a patient's home or residence, or when it has not been ordered by a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070791 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070791: PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070791
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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