# K150361: ViSi Mobile Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Sotera Wireless, Inc.
- Decided: Apr 30, 2015 after 77 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: 11 generations back to K962603 (1997). 44 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143751: Visi Mobile Monitoring System, Sotera Wireless, Inc. (2015) Summary page 4.

## Most influential descendants
- K183067: Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System (2019), 4 descendants of its own
- K203208: Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (2022), 3 descendants of its own
- K233963: Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) (2025), 0 descendants of its own
- K233956: Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) (2025), 0 descendants of its own
- K223721: Masimo Stork (2023), 0 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 (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), noninvasive 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 ViSi Mobile Remote Viewers through wireless 802.11 communication.

Source page: https://510kreport.com/device/K150361
Methodology: https://510kreport.com/methodology