510(k) · Cleared
ClearedBeneview T Series Patient Monitors, Models T8, T6 and T5
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 23, 2008 as substantially equivalent to K070791 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2007) and 4 other predicates after a 215-day review. Its family tree reaches back 13 generations to 1994. 2 later devices descend from it.
- Decided
- Jun 23, 2008
- Review
- 215 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 13 generations to K941811 (1994). 108 ancestors in all, the oldest K842616 (1984). 2 later devices descend from it, 1 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 deviceK073280 Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK110922 Patient MonitorEdan Instruments, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK120631 Patient MonitorAdvanced Instruments, Inc. · 2012
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 deviceK073280 Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
Most influential descendants
Showing 2 of 2 · See allView 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) | K073280 | Beneview T Series Patient Monitors, Models T8, T6 and T5 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| +1 | K110922 | Patient Monitor | Edan Instruments, Inc. | 2011 | 1 |
| +2 | K120631 | Patient Monitor | Advanced Instruments, Inc. | 2012 | — |
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 | 6 | 0 |
| 1993 | 5 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 6 | 0 |
| 1997 | 7 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 15 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 7 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 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.
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 |
|---|---|---|---|
| * | K070791 | PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressSummary page 2…Class II 21 CFR 870.2770 Impedance plethysmograph Class HI Legally Marketed Predicate Devices: 1) K070791, PM-9000 Express Patient Monitor, SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. 2)… | 2007 |
| * | K041294 | Biozdx Hemodynamic MonitorSummary page 2…Devices: 1) K070791, PM-9000 Express Patient Monitor, SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. 2) K041294, BioZDx Hemodynamic Monitor, Cardiodynamics International Corp. 3) K040183, BISX, ASPECT MEDICAL SYSTEMS, INC.… | 2004 |
| * | K040183 | BISXSummary page 2…MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. 2) K041294, BioZDx Hemodynamic Monitor, Cardiodynamics International Corp. 3) K040183, BISX, ASPECT MEDICAL SYSTEMS, INC. 4) K042601, CAPNOSTAT 5, RESPIRONICS NOVAMETRIX, INC. 5)… | 2004 |
| * | K042601 | Capnostat 5Summary page 2…2) K041294, BioZDx Hemodynamic Monitor, Cardiodynamics International Corp. 3) K040183, BISX, ASPECT MEDICAL SYSTEMS, INC. 4) K042601, CAPNOSTAT 5, RESPIRONICS NOVAMETRIX, INC. 5) K041790, DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITO… | 2004 |
| * | K041790 | Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE03 and LCANE03A SoftwareSummary page 2…tional Corp. 3) K040183, BISX, ASPECT MEDICAL SYSTEMS, INC. 4) K042601, CAPNOSTAT 5, RESPIRONICS NOVAMETRIX, INC. 5) K041790, DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR with datex-ohmeda Description: The BeneView T S… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110922 | Patient Monitor | 2011 | 1 |
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 14 years and passes through 6 companies; a new generation was cleared every 4 months on median.
- 14 of the 108 ancestors have a recall of any class.
- Of its descendants, K110922 (Edan Instruments, Inc., 2011) has gone furthest, with 1 descendant 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. 2008, 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 BeneView T Series patient monitors including models BeneView T8, BeneView T6 and BeneView T5 are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG(3-1ead or 5-lead or 12-lead selectable), arrhythmia detection, ST Segment analysis, Heart Rate(HR), Respiration Rate(RESP), Temperature (TEMP), Pulse Oxygen Saturation (SP02), Pulse Rate(PR), Non-invasive Blood Pressure…
Read the full statement (162 words)
The BeneView T Series patient monitors including models BeneView T8, BeneView T6 and BeneView T5 are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG(3-1ead or 5-lead or 12-lead selectable), arrhythmia detection, ST Segment analysis, Heart Rate(HR), Respiration Rate(RESP), Temperature (TEMP), Pulse Oxygen Saturation (SP02), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS) and respiration mechanics (RM).
The arrhythmia detection, ST Segment analysis, BIS and RM monitoring are not intended for neonatal patients. The ICG is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 159kg. Other parameters can be applied to a single adult, pediatric or neonatal patient.
The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport, hospital ambulance, or home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073280: Beneview T Series Patient Monitors, Models T8, T6 and T5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073280
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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