510(k) · Cleared
Recalled · Class II · 2012PM-9000 Express 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. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on May 4, 2006 as substantially equivalent to K043348 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2005) and 1 other predicate after a 167-day review. Its family tree reaches back 10 generations to 1994. 71 later devices descend from it. It has been recalled once.
- Decided
- May 4, 2006
- Review
- 167 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 10 generations to K941811 (1994). 76 ancestors in all, the oldest K842616 (1984). 71 later devices descend from it, 6 citing it directly.
- Root · 10 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 6 generations between
- 3 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 2 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 1 generation backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- This deviceK053234 PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- Descendant · cites it directly · 47 of its ownK070791 PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- Descendant · 2 generations on · 19 of its ownK072581 PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- Descendant · 2 generations on · 19 of its ownK072346 PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- Descendant · 3 generations on · 16 of its ownK100046 M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd. · 2010
- Descendant · cites it directly · 13 of its ownK123711 Patient MonitorShenzhen Creative Industry Co., Ltd. · 2013
Show all 10 generations
- Root · 10 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 9 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 8 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 7 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 6 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 5 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 4 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 3 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 2 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 1 generation backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- This deviceK053234 PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 71 · See all- K070791PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · cites it directly47descendants
- K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 2 generations on19descendants
- K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · 2 generations on19descendants
- K100046M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd. · 2010 · 3 generations on16descendants
- K123711Patient MonitorShenzhen Creative Industry Co., Ltd. · 2013 · cites it directly13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −9 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −8 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −7 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −6 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −5 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −4 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −3 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −2 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −1 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| 0 (this device) | K053234 | PM-9000 Express Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| +1 | K070791 | PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| +2 | K072581 | PM-60 Pulse Oximeter | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| +2 | K072346 | PM-7000 Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| +3 | K100046 | M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000 | Guangdong Biolight Meditech Co., Ltd. | 2010 | — |
| +1 | K123711 | Patient Monitor | Shenzhen Creative Industry Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 4 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K043348 | Modification to PM-8000 Patient MonitorSummary page 2…Class 11 2 1 CFR 868.1 720 Oxygen gas analyzer Class 11 Legally Marketed Predicate Device: K043348 PM-8000 Patient Monitor (by Mindray Co., Ltd.) K030038 IntelliVue Models MP6O, MP70 and MP90 Patient Mo… | 2005 |
| * | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…Summary page 2…Class 11 Legally Marketed Predicate Device: K043348 PM-8000 Patient Monitor (by Mindray Co., Ltd.) K030038 IntelliVue Models MP6O, MP70 and MP90 Patient Monitors with portal Technology and M3 185 opt.… | 2003 |
What descends from it? (71)
See all 716 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070791 | PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express | 2007 | 47 |
| K123711 | Patient Monitor | 2013 | 13 |
| K080173 | STAR 55 | 2008 | 5 |
| K100394 | Multi-Parameter Patient Monitor, Model# PMS8210A | 2010 | 1 |
| K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor | 2015 | 0 |
| K082887 | PM-1000F+Patient Monitor | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 5, 2012 | Class II | Z-0742-2013 | Device Design | Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 7 of the 76 ancestors have a recall of any class.
- Of its descendants, K070791 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2007) has gone furthest, with 47 descendants of its own.
- 4 other devices also cite its predicate K043348.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The PM-9000 Express Patient Monitor is a vital signs monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PM-9000 Express Patient Monitor has many features and functions, yet is easy to use through an integrated keypad, knob and an intuitive menu system. The patient parameters that can be monitored by PM-9000 Express Patient Monitor are: ECG(3-lead or 5-lead selectable), Heart Rate(HR), Pulse Rate(PR)…
Read the full statement (171 words)
The PM-9000 Express Patient Monitor is a vital signs monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PM-9000 Express Patient Monitor has many features and functions, yet is easy to use through an integrated keypad, knob and an intuitive menu system.
The patient parameters that can be monitored by PM-9000 Express Patient Monitor are: ECG(3-lead or 5-lead selectable), Heart Rate(HR), Pulse Rate(PR), Respiration Rate(RESP), Nan-invasive Blood Pressure (NIBP), Arterial Hemoglobin Oxygen Saturation(SpO 2), Temperature (TEMP), Invasive Blood Pressure(IBPD), Carbon Dioxide (002) 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 PM-9000 Express Patient Monitor is intended for use in a health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment.
The PM-9000 Express Patient Monitor is not recommended 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/K053234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053234: PM-9000 Express Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053234
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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