# K080192: Hypervisor VI Central Monitoring System (Including TMS)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Apr 3, 2008 after 69 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: 4 generations back to K933143 (1994). 20 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062194: Hypervisor VI Central Monitoring System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2007) Summary page 2.
- K983996: Spacelabs Medical Ultraview Digital Telemtry System, Spacelabs Medical, Inc. (1999) Summary page 2.

## Most influential descendants
- K132036: Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016) (2014), 17 descendants of its own
- K150632: Hypervisor IX Monitoring System (2015), 14 descendants of its own
- 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

## Recalls of this device
- Nov 28, 2012 · Class II · Z-0798-2013: 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 u
- May 12, 2011 · Class II · Z-0630-2013: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K080192
Methodology: https://510kreport.com/methodology