510(k) · Cleared
Recalled · Class II · 2018BeneVision Central Monitoring System
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 20, 2017 as substantially equivalent to K150632 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2015) after a 213-day review. Its family tree reaches back 7 generations to 1994. 12 later devices descend from it. It has been recalled once.
- Decided
- Apr 20, 2017
- Review
- 213 days
- Class
- Class II
- Product code
- MSX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K933143 (1994). 23 ancestors in all, the oldest K781836 (1978). 12 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 6 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- 5 generations backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- 4 generations backK983996 Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc. · 1999
- 3 generations backK080192 Hypervisor VI Central Monitoring System (Including TMS)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · Recalled
- 2 generations backK132036 Hypervisor Central Monitoring System (Including Telemetry Monitoring…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014
- 1 generation backK150632 Hypervisor IX Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
- This deviceK162607 BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017
- Descendant · cites it directly · 11 of its ownK183238 BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2019
- Descendant · 2 generations on · 10 of its ownK193391 BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2020 · Recalled
- Descendant · 3 generations on · 3 of its ownK220058 BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2022 · Recalled
- Descendant · 3 generations on · 2 of its ownK223567 CNS-2101 Central MonitorNihon Kohden Corporation · 2023
- Descendant · 4 generations on · 1 of its ownK242750 Central StationNihon Kohden Digital Health Solutions, LLC · 2025
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K183238BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2019 · cites it directly11descendants
- K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2020 · 2 generations on10descendants
- K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2022 · 3 generations on3descendants
- K223567CNS-2101 Central MonitorNihon Kohden Corporation · 2023 · 3 generations on2descendants
- K242750Central StationNihon Kohden Digital Health Solutions, LLC · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −6 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| −5 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| −4 | K983996 | Spacelabs Medical Ultraview Digital Telemtry System | Spacelabs Medical, Inc. | 1999 | — |
| −3 | K080192 | Hypervisor VI Central Monitoring System (Including TMS) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | 2 |
| −2 | K132036 | Hypervisor Central Monitoring System (Including Telemetry Monitoring System… | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2014 | — |
| −1 | K150632 | Hypervisor IX Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 2 |
| 0 (this device) | K162607 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017 | — |
| +1 | K183238 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019 | — |
| +2 | K193391 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020 | 2 |
| +3 | K220058 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022 | 1 |
| +3 | K223567 | CNS-2101 Central Monitor | Nihon Kohden Corporation | 2023 | — |
| +4 | K242750 | Central Station | Nihon Kohden Digital Health Solutions, LLC | 2025 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K150632 | Hypervisor IX Monitoring SystemSummary page 6…vasive DQA- Oximeter DSB- Impedance plethysmograph Predicate Device: K150632 –Hypervisor IX Monitoring System Reference Predicates: K152902–Passport Series Patient Monitors (Passport 12m,… | 2015 |
| † | K152902 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | 2016 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183238 | BeneVision Central Monitoring System | 2019 | 11 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 30, 2018 | Class II | Z-0170-2019 | Software design | The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The anomaly causes some ECG waveforms to appear as a flat line at the centralized… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 23 ancestors have a recall of any class.
- Of its descendants, K183238 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2019) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K150632.
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. 2017, 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 indications for use of the BeneVision Central Monitoring System include: • Real time viewing of patient clinical data and alarms • Storage and Historical review of patient clinical data and alarms • Printing of real time and historical patient data • Configuration of local settings as well as synchronizing settings across the network to a remote device • Transfer of patient clinical data and settings between several CentralStations The BeneVision…
Read the full statement (392 words)
The indications for use of the BeneVision Central Monitoring System include:
• Real time viewing of patient clinical data and alarms
• Storage and Historical review of patient clinical data and alarms
• Printing of real time and historical patient data
• Configuration of local settings as well as synchronizing settings across the network to a remote device
• Transfer of patient clinical data and settings between several CentralStations
The BeneVision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wired), Wireless WIFI (WLAN), and Wireless WMTS.
The BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors; The BeneVision Central Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors.
The telemetry monitoring systems are designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The BeneVision Central Monitoring System supports Telemetry Systems: TMS-6016, Telepack-608, TMS60, and TM80.
• The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data.
• The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data.
• The TMS60 transmitter is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.
• The TM80 telemetry monitor is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be reviewed locally on the display of the monitor. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TM80.
The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162607 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162607: BeneVision Central Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162607
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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