# K172586: Vios Monitoring System™ Model 2050

- Pathway: 510(k) (Traditional)
- Applicant: Vios Medical, Inc.
- Decided: Jun 22, 2018 after 298 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K962603 (1997). 100 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 103 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150992: Vios Monitoring System, Vios Medical, Inc. (2015) Summary page 4.
- K152341: ViSi Mobile Monitoring System, Sotera Wireless, Inc. (2015) Summary page 4.
- K092101: Reusable Pulse Oximeter Sensor, Model 8000 Series, Nonin Medical, Inc. (2009) Summary page 4.

## Most influential descendants
- K241728: Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 (2025), 0 descendants of its own
- K232354: Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software (2024), 0 descendants of its own

## Recalls of this device
- Aug 9, 2024 · Class II · Z-1292-2025: Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivity issues.
- Apr 22, 2024 · Class II · Z-1069-2025: During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs
- Jun 6, 2023 · Class II · Z-1169-2025: A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning con
- Jun 21, 2021 · Class II · Z-0956-2025: During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs

## 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 rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.

Source page: https://510kreport.com/device/K172586
Methodology: https://510kreport.com/methodology