510(k) · Cleared
Recalled · Class II · 2026Beneview T Series Patient Monitors, Models Beneview 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 Aug 30, 2010 after a 385-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 35 later devices descend from it. It has been recalled 5 times.
- Decided
- Aug 30, 2010
- Review
- 385 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 5
- Predicates
- 0
35 later devices descend from it, 5 citing it directly.
- This deviceK092449 Beneview T Series Patient Monitors, Models Beneview T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- Descendant · cites it directly · 10 of its ownK132075 Passport M Series Patient Monitoring (Including Models Passport 17M…Mindray North America · 2014
- Descendant · 2 generations on · 9 of its ownK143195 Passport Series Patient Monitors (including Passport 17M, Passport…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014 · Recalled
- Descendant · cites it directly · 8 of its ownK160981 Patient MonitorEdan Instruments, Inc. · 2016 · Recalled
- Descendant · cites it directly · 8 of its ownK123211 A5 Anesthesia Delivery SystemDatascope Corp., Patient Monitoring Division · 2013 · Recalled
- Descendant · cites it directly · 7 of its ownK123074 Imec, Ipm and Beneview T1 Patient MonitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2013
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America · 2014 · cites it directly10descendants
- K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014 · 2 generations on9descendants
- K160981Patient MonitorEdan Instruments, Inc. · 2016 · cites it directly8descendants
- K123211A5 Anesthesia Delivery SystemDatascope Corp., Patient Monitoring Division · 2013 · cites it directly8descendants
- K123074Imec, Ipm and Beneview T1 Patient MonitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2013 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092449 | Beneview T Series Patient Monitors, Models Beneview T8, T6 and T5 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| +1 | K132075 | Passport M Series Patient Monitoring (Including Models Passport 17M and… | Mindray North America | 2014 | — |
| +2 | K143195 | Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2014 | 1 |
| +1 | K160981 | Patient Monitor | Edan Instruments, Inc. | 2016 | 1 |
| +1 | K123211 | A5 Anesthesia Delivery System | Datascope Corp., Patient Monitoring Division | 2013 | 1 |
| +1 | K123074 | Imec, Ipm and Beneview T1 Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (35)
See all 355 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2026 | Class III | Z-0113-2027 | Labeling design | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| Jul 27, 2015 | Class II | Z-2737-2015 | Under Investigation by firm | The DPM 7 Monitors may display a black screen. |
| Oct 6, 2014 | Class II | Z-0837-2015 | Process control | Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monitor where the IBP measurement data may be displayed in an incorrect IBP tile on the monitors display. |
| Mar 5, 2014 | Class II | Z-1611-2014 | No Marketing Application | The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing. |
| Aug 11, 2010 | Class II | Z-0513-2013 | Device Design | There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and Ventilation Calculations. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K132075 (Mindray North America, 2014) has gone furthest, with 10 descendants of its own.
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. 2010, 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 | — |
https://510kreport.com/device/K092449 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092449: Beneview T Series Patient Monitors, Models Beneview T8, T6 and T5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092449
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026