# K130709: Visi Mobile Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Sotera Wireless, Inc.
- Decided: Oct 7, 2013 after 206 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: 7 generations back to K962603 (1997). 25 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112478: Visi Mobile Monitoring System, Sotera Wireless, Inc. (2012)
- K082599: Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500AT, Cnsystem Medizintechnik AG (2008) Summary page 1.

## Most influential descendants
- K143751: Visi Mobile Monitoring System (2015), 17 descendants of its own
- K150992: Vios Monitoring System (2015), 7 descendants of its own
- K150361: ViSi Mobile Monitoring System (2015), 6 descendants of its own
- K183067: Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System (2019), 4 descendants of its own
- K152341: ViSi Mobile Monitoring System (2015), 4 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 (18 years or older) patients. It is indicated for ECG (3 or 5 leadwire), respiration rate, heart rate, non-invasive blood pressure (NIBP), continuous non-invasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2 ), pulse rate, and skin temperature in hospital-based facilities; including general medical-surgical floors, intermediate care floors, and emergency departments. Continuous non-invasive blood pressure (cNIBP) testing has not been conducted on ambulatory patients.

Source page: https://510kreport.com/device/K130709
Methodology: https://510kreport.com/methodology