# K241728: Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050

- Pathway: 510(k) (Traditional)
- Applicant: Murata Vios, Inc.
- Decided: Jan 23, 2025 after 223 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- 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). 130 ancestors in all.
No later device cites it as a predicate yet.
1 of 131 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130709: Visi Mobile Monitoring System, Sotera Wireless, Inc. (2013) Summary page 5.
- 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.

## 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 (NIBP) continuously, and patient posture and activity. VMS allows for the input of non-invasive blood pressure and body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters. The non-invasive Blood Pressure Tracking feature is based on Pulse Arrival Time (PAT), which is obtained utilizing ECG and PPG signals following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment. The Vios Central Station Monitor (CSM) and Central Server (CS) Software (SW) is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSM SW and 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/K241728
Methodology: https://510kreport.com/methodology