# K142827: Visi Mobile Monitoring System, Visi Mobile Chest Sensor

- Pathway: 510(k) (Abbreviated)
- Applicant: Sotera Wireless, Inc.
- Decided: Jul 20, 2015 after 293 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962603 (1997). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062282: Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0, Monebo Technologies, Inc. (2007) Summary page 5.
- K052160: Acuity Central Station, Model 020XXXXX (Note:  Xxxxx = Various Config.), Welch Allyn, Inc. (2005) Summary page 5.
- K122036: Visi Mobile Monitoring System, Sotera Wireless, Inc. (2012) Summary page 5.
- K130709: Visi Mobile Monitoring System, Sotera Wireless, Inc. (2013) Summary page 5.

## 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, heart rate, noninvasive blood pressure (NIBP), continuous non-invasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, skin temperature, basic arrhythmia analysis (Ventricular Tachycardia, Ventricular Fibrillation, Asystole, Atrial Fibrillation/Atrial Flutter) and alarm in hospital-based facilities; including general medical-surgical floors, intermediate care floors, and emergency departments. Continuous non-invasive blood pressure (cNIBP) measurements have not been evaluated on patients during ambulation. The basic arrhythmia analysis feature is intended for use on patients 18 years of age and older. It has not been evaluated on pediatric patients or neonates. The arrhythmia analysis feature is intended for use by healthcare professionals trained in the identification and treatment of arrhythmia events. Automated arrhythmia analysis is an adjunct to clinical assessment; clinician review of the analysis should precede any therapeutic intervention. The ViSi Mobile Monitoring System may be used as standalone devices or networked to a ViSi Mobile Remote Viewer through wireless 802.11 communication.

Source page: https://510kreport.com/device/K142827
Methodology: https://510kreport.com/methodology