# K150992: Vios Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Vios Medical, Inc.
- Decided: Dec 16, 2015 after 245 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: 11 generations back to K962603 (1997). 60 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143751: Visi Mobile Monitoring System, Sotera Wireless, Inc. (2015) Summary page 4.
- K141167: Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and Secure Server Software Library), Vitalconnect, Inc. (2014) Summary page 4.

## Most influential descendants
- K172586: Vios Monitoring System™ Model 2050 (2018), 2 descendants of its own
- K181196: Caretaker Remote Display App and Caretaker Software Library (2018), 1 descendant of its own
- K172011: LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) (2018), 1 descendant of its own
- 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

## Indications for use
The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological and vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of ECG, heart rate, pulse rate, functional oxygen saturation of arterial hemoglobin, and axillary temperature. VMS allows for the input of non-invasive blood pressure 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/K150992
Methodology: https://510kreport.com/methodology