510(k) · Cleared
Recalled · Class II · 2012Hypervisor VI Central Monitoring System (Including TMS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MSX System, Network And Communication, Physiological Monitors
Cleared on Apr 3, 2008 as substantially equivalent to K062194 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2007) and 1 other predicate after a 69-day review. Its family tree reaches back 4 generations to 1994. 20 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 3, 2008
- Review
- 69 days
- Class
- Class II
- Product code
- MSX
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 4 generations to K933143 (1994). 20 ancestors in all, the oldest K781836 (1978). 20 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 3 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- 2 generations backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- 1 generation backK983996 Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc. · 1999
- This deviceK080192 Hypervisor VI Central Monitoring System (Including TMS)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- Descendant · cites it directly · 17 of its ownK132036 Hypervisor Central Monitoring System (Including Telemetry Monitoring…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014
- Descendant · 2 generations on · 14 of its ownK150632 Hypervisor IX Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
- Descendant · 3 generations on · 12 of its ownK162607 BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017 · Recalled
- Descendant · 4 generations on · 11 of its ownK183238 BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2019
- Descendant · 5 generations on · 10 of its ownK193391 BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2020 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K132036Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014 · cites it directly17descendants
- K150632Hypervisor IX Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 2 generations on14descendants
- K162607BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017 · 3 generations on12descendants
- K183238BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2019 · 4 generations on11descendants
- K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2020 · 5 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −3 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| −2 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| −1 | K983996 | Spacelabs Medical Ultraview Digital Telemtry System | Spacelabs Medical, Inc. | 1999 | — |
| 0 (this device) | K080192 | Hypervisor VI Central Monitoring System (Including TMS) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| +1 | K132036 | Hypervisor Central Monitoring System (Including Telemetry Monitoring System… | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2014 | — |
| +2 | K150632 | Hypervisor IX Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 2 |
| +3 | K162607 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017 | 1 |
| +4 | K183238 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019 | — |
| +5 | K193391 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 MSX? 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 MSX device
- #1 K242750 Central Stationscore 21.5 · 31 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 |
|---|---|---|---|
| * | K062194 | Hypervisor VI Central Monitoring SystemSummary page 2…0.29 10 Transmitters and Receivers, Physiological Signal, Radiofrequency Legally Marketed Predicate Device: K062194 HYPERVISOR VI Central Monitoring System, Shenzhen Mindray Bio-Medical Electronics Co., LTD. K983996… | 2007 |
| * | K983996 | Spacelabs Medical Ultraview Digital Telemtry SystemSummary page 2…Legally Marketed Predicate Device: K062194 HYPERVISOR VI Central Monitoring System, Shenzhen Mindray Bio-Medical Electronics Co., LTD. K983996 Spacelabs Medical Ultraview Digital Telemetry System, Spacelabs Medical, Inc. Description: Central Monitoring System n… | 1999 |
What descends from it? (20)
See all 203 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 |
|---|---|---|---|---|
| Nov 28, 2012 | Class II | Z-0798-2013 | Software design | Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecting cardiac… |
| May 12, 2011 | Class II | Z-0630-2013 | Software design | There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K132036 (Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd., 2014) has gone furthest, with 17 descendants of its own.
- 2 other devices also cite its predicate K062194.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, 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 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
The CMS network transfers information between HYPERVISOR VI Central Monitoring System and other networked devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and/or WLAN connections. CMS can be used for remote monitor management, storing, printing, reviewing or processing of information from networked devices, and it is operated by medical personnel in hospitals or medical institutions.
Telemetry Monitoring System is a sub-system of CMS, intended to obtain ECG and SpO2 physiological information from adult and pediatric patients, and send it to CMS via WMTS frequency within a defined coverage area.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080192 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080192: Hypervisor VI Central Monitoring System (Including TMS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080192
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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