# K112650: Connexall Suite of Software Products

- Pathway: 510(k) (Traditional)
- Applicant: Connexall USA, Inc.
- Decided: Feb 1, 2012 after 142 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: 6 generations back to K962827 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102974: Intellisphere Event Managment System Rel. 10.00, Philips Medical Systems (2011) Summary page 1.

## Indications for use
The intended use of the Connexall Suite of Software Products is to provide an interface with clinical systems to forward information associated to the particular event to the designated display device(s). For medical, near real time alarms, the Connexall Suite of Software Products is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. The Connexall Suite of Software Products does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audio and/or vibrating mechanism upon receipt of the alert. The Connexall Suite of Software Products is intended for use as a secondary alarm. It does not replace the primary alarm function on the monitor.

Source page: https://510kreport.com/device/K112650
Methodology: https://510kreport.com/methodology