# K232354: Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software

- Pathway: 510(k) (Traditional)
- Applicant: Murata Vios, Inc.
- Decided: Mar 22, 2024 after 228 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K962603 (1997). 131 ancestors in all.
No later device cites it as a predicate yet.
1 of 132 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172586: Vios Monitoring System™ Model 2050, Vios Medical, Inc. (2018) Summary page 5.
- K173107: Vios Central Station Monitor Software, Vios Central Server Software, Vios Medical, Inc. (2018) Summary page 5.
- K180472: ViSi Mobile Monitoring System, Sotera Wireless, Inc. (2018) Summary page 5.

## Indications for use
The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, and patient posture and activity. VMS allows for the input of body temperature, and can display data from peripheral devices. VMS can generate alerts when the physiological vital signs fall outside of selected parameters. VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/ Ventricular Fibrillation and Atrial Fibrillation/ Atrial Flutter) are detected. The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmias and medical interventions. The Vios CSM/CS Software is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSM/CS SW receives, stores, manages, and displays patient physiological and waveform data and alarms generated by Vios proprietary patient vitals monitoring software.

Source page: https://510kreport.com/device/K232354
Methodology: https://510kreport.com/methodology