510(k) · Cleared
ClearedPM-7000 Patient Monitor
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 Nov 29, 2007 as substantially equivalent to K070791 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2007) after a 100-day review. Its family tree reaches back 13 generations to 1994. 19 later devices descend from it.
- Decided
- Nov 29, 2007
- Review
- 100 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K941811 (1994). 89 ancestors in all, the oldest K842616 (1984). 19 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 9 generations between
- 3 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 2 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 1 generation backK070791 PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- This deviceK072346 PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- Descendant · cites it directly · 16 of its ownK100046 M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd. · 2010
- Descendant · 2 generations on · 7 of its ownK131762 Handheld MonitorGuangdong Biolight Meditech Co., Ltd. · 2014
- Descendant · 3 generations on · 5 of its ownK150869 Checkme Pro Health MonitorViatom Technology Co., Ltd. · 2015
- Descendant · 2 generations on · 3 of its ownK113833 Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd. · 2012
- Descendant · 4 generations on · 2 of its ownK191088 Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd. · 2019
Show all 13 generations
- Root · 13 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 12 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 11 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 10 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 9 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 8 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 7 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 6 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 5 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 4 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 3 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 2 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 1 generation backK070791 PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- This deviceK072346 PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K100046M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd. · 2010 · cites it directly16descendants
- K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd. · 2014 · 2 generations on7descendants
- K150869Checkme Pro Health MonitorViatom Technology Co., Ltd. · 2015 · 3 generations on5descendants
- K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd. · 2012 · 2 generations on3descendants
- K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd. · 2019 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −12 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −11 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −10 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −9 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −8 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −7 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −6 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −5 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −4 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −3 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −2 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −1 | K070791 | PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| 0 (this device) | K072346 | PM-7000 Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| +1 | K100046 | M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000 | Guangdong Biolight Meditech Co., Ltd. | 2010 | — |
| +2 | K131762 | Handheld Monitor | Guangdong Biolight Meditech Co., Ltd. | 2014 | — |
| +3 | K150869 | Checkme Pro Health Monitor | Viatom Technology Co., Ltd. | 2015 | — |
| +2 | K113833 | Vital Signs Monitor | Guangdong Biolight Meditech Co., Ltd. | 2012 | — |
| +4 | K191088 | Checkme O2 Pulse Oximeter | Shenzhen Viatom Technology Co., Ltd. | 2019 | — |
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 |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2021 | 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.
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? (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 |
|---|---|---|---|
| * | K070791 | PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressSummary page 3…ordered by a physician. Comparison of Technological Characteristics: Both the PM-7000 Patient Monitor and the predicate PM-9000 Express Patient Monitor (K070791) have the same parameters modules, measurement accessories and modules (software/hardware). That is to say, they have iden… | 2007 |
What descends from it? (19)
See all 193 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 89 ancestors have a recall of any class.
- Of its descendants, K100046 (Guangdong Biolight Meditech Co., Ltd., 2010) has gone furthest, with 16 descendants of its own.
- 5 other devices also cite its predicate K070791.
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-7000 Patient Monitor is 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 the PM-7000 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…
Read the full statement (162 words)
The PM-7000 Patient Monitor is 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 the PM-7000 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 (CO 2), and Anaesthetic Gases(AG).
Its 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 ranging 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 Monitor is 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/K072346 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072346: PM-7000 Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072346
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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