# K133586: Visi Mobile Monitioring System

- Pathway: 510(k) (Special)
- Applicant: Sotera Wireless, Inc.
- Decided: Dec 18, 2013 after 27 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: 9 generations back to K962603 (1997). 36 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122036: Visi Mobile Monitoring System, Sotera Wireless, Inc. (2012) 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 patients. It is indicated for ECG (3 or 5 leadwire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), non-invasive 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 central station through wireless 802.11 communication.

Source page: https://510kreport.com/device/K133586
Methodology: https://510kreport.com/methodology