# K122036: Visi Mobile Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Sotera Wireless, Inc.
- Decided: Aug 15, 2012 after 35 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962603 (1997). 35 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 56 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)
- K033378: Vital Signs Monitor, Propaq LT, Welch Allyn Protocol, Inc. (2004) Summary page 1.
- K002725: Micropaq, Models 402 and 404, Protocol Systems, Inc. (2000) Summary page 1.
- K022453: Modification to Acuity Central Monitoring System, Welch Allyn Protocol, Inc. (2002) Summary page 1.

## Most influential descendants
- K133586: Visi Mobile Monitioring System (2013), 18 descendants of its own
- 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

## Recalls of this device
- May 23, 2013 · Class II · Z-1818-2013: Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.
- May 23, 2013 · Class II · Z-1817-2013: Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.

## 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 (NIEP), 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/K122036
Methodology: https://510kreport.com/methodology