# K152341: ViSi Mobile Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Sotera Wireless, Inc.
- Decided: Dec 14, 2015 after 117 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- 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). 52 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 57 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.
- K130339: Clinical Alert Notification, Extension, Inc. (2013) Summary page 4.

## Most influential descendants
- K172586: Vios Monitoring System™ Model 2050 (2018), 2 descendants of its own
- K180472: ViSi Mobile Monitoring 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 ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including, general medical-surgical floors, intermediate care floors, and emergency departments. The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication. The ViSi Mobile InSight is an optional secondary notification system that communicates alarms directly to an assigned caregiver. It is intended to supplement the primary alarming devices which originate in the ViSi Mobile patient worn device.

Source page: https://510kreport.com/device/K152341
Methodology: https://510kreport.com/methodology