# K112282: M Visum Alert Alarm Management System

- Pathway: 510(k) (Traditional)
- Applicant: Mvisum, Inc.
- Decided: Nov 4, 2011 after 87 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- 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: 1 generation back to K990378 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990378: Statview System, Data Critical Corp. (1999) Summary page 1.
- K061994: Web Viewer, Pocket Viewer and Cellular Viewer with L- WEB05 Software, GE Healthcare (2006) Summary page 1.

## Indications for use
The mVisum Alert Alarm Management System is software intended for use to display status and alarm events from other medical devices and patient information systems and associated physiological and other patient information. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. It is intended to be a secondary means of annunciating and displaying patient alarm and physiological information to mobile healthcare providers. The mVisum Alert Alarm Management System is limited to use by qualified medical professionals who have been trained on the use of the system. It is intended to supplement and not to replace any part of the current patient monitoring systems. It is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.

Source page: https://510kreport.com/device/K112282
Methodology: https://510kreport.com/methodology