# K112478: Visi Mobile Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Sotera Wireless, Inc.
- Decided: Mar 22, 2012 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K872291 (1987). 10 ancestors in all.
24 later devices descend from it; 3 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043517: Transmitter, ZS-940PA Series, Nihon Kohden America, Inc. (2005) Summary page 1.
- K082812: Omron Model HBP-2070 Vital Signs Monitor, Omron Healthcare, Inc. (2008) Summary page 1.

## Most influential descendants
- K122036: Visi Mobile Monitoring System (2012), 20 descendants of its own
- K130709: Visi Mobile Monitoring System (2013), 19 descendants of its own
- 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

## 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 EGG (3 or 5 leadwire), respiration rate (RESP), heart rate (H-R), 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.

Source page: https://510kreport.com/device/K112478
Methodology: https://510kreport.com/methodology