# K150632: Hypervisor IX Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jul 6, 2015 after 117 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: 6 generations back to K933143 (1994). 22 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132036: Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016), Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. (2014) Summary page 6.

## Most influential descendants
- K162607: BeneVision Central Monitoring System (2017), 12 descendants of its own
- 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

## Recalls of this device
- Jul 14, 2017 · Class II · Z-0554-2018: A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate.
- Sep 8, 2016 · Class II · Z-0321-2017: Mindray has become aware that the TD60 Display Telemetry Transmitter used with the BeneVision Central Station may crack on the bezel surrounding the display and also the transmitter may not power on o

## Indications for use
The indications for use of the Hypervisor IX 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 Hypervisor IX Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in a hospital or clinical environment 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 Hypervisor IX Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors; The Hypervisor IX Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the Hypervisor IX Monitoring System for data received from compatible monitors. The Hypervisor IX Monitoring System includes several Telemetry monitoring subsystems all of which operate in the 608M WMTS frequency range within a defined coverage area. All of the supported telemetry systems transmit data to the CentralStation for processing, display, and alarm. • The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data. The CentralStation will support ECG, Heart Rate, SpO2, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS-6016. • The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data. The CentralStation will support ECG, Heart Rate, SpO2, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the Panorama Telepack-608. • The TMS60 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60. The Hypervisor IX Monitoring System is intended for use in a hospital or other clinical environment under the direct supervision of a licensed healthcare practitioner.

Source page: https://510kreport.com/device/K150632
Methodology: https://510kreport.com/methodology