# K162607: BeneVision Central Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Apr 20, 2017 after 213 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K933143 (1994). 23 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150632: Hypervisor IX Monitoring System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2015) Summary page 6.

## Most influential descendants
- K183238: BeneVision Central Monitoring System (2019), 11 descendants of its own
- K193391: BeneVision Central Monitoring System (2020), 10 descendants of its own
- K220058: BeneVision Central Monitoring System (2022), 3 descendants of its own
- K223567: CNS-2101 Central Monitor (2023), 2 descendants of its own
- K242750: Central Station (2025), 1 descendant of its own

## Recalls of this device
- Aug 30, 2018 · Class II · Z-0170-2019: 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 ap

## Indications for use
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.

Source page: https://510kreport.com/device/K162607
Methodology: https://510kreport.com/methodology