# K193391: BeneVision Central Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: May 21, 2020 after 167 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 29 generations back to K941811 (1994). 191 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 202 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183238: BeneVision Central Monitoring System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2019) Summary page 6.
- K172226: MX40 Release B.07, Philips Medical Systems (2017) Summary page 6.

## Most influential descendants
- 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
- K232694: Central Monitoring System (MFM-CMS) (2024), 1 descendant of its own
- K231477: Infinity CentralStation Wide, Infinity M300, Infinity M300+ (2023), 1 descendant of its own

## Recalls of this device
- May 27, 2021 · Class III · Z-2108-2021: Telepack may not power on when using the 3AA battery cradle.
- Feb 22, 2021 · Class II · Z-1254-2021: BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation resumes. If a freeze occur, patients monitored on a telemetry transmitter will no longer communicate d

## 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, TM80, and TM70. • 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/TM70 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 analyzed, alarmed, stored, reviewed locally on the display of the monitor, and the CentralStation can configure and display the physiological parameters from the TM80/TM70. 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/K193391
Methodology: https://510kreport.com/methodology