# K193043: Critical Alert CommonPath Enterprise

- Pathway: 510(k) (Traditional)
- Applicant: Critical Alert
- Decided: May 11, 2020 after 193 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: 7 generations back to K962827 (1997). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180566: Unite Connect for Clinical Systems, Ascom Sweden AB (2018) Summary page 4.
- K130208: Bernoulli Enterprise Software, Cardiopulmonary Corp. (2013) Summary page 4.

## Most influential descendants
- K243270: TigerConnect Alarm Management (2025), 0 descendants of its own

## Indications for use
The intended use of Critical Alert CommonPath Enterprise 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, Critical Alert CommonPath Enterprise is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. Critical Alert CommonPath Enterprise does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audible and/or vibrating mechanism upon receipt of the alert. Critical Alert CommonPath Enterprise is intended for use as a secondary alert. It does not replace the alarm function on the primary device.

Source page: https://510kreport.com/device/K193043
Methodology: https://510kreport.com/methodology