# K180566: Unite Connect for Clinical Systems

- Pathway: 510(k) (Special)
- Applicant: Ascom Sweden AB
- Decided: Apr 3, 2018 after 29 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). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103634: Ascom Clinicalconnex  Cardiomax, Ascom (Us), Inc. (2011) Summary page 4.

## Most influential descendants
- K193043: Critical Alert CommonPath Enterprise (2020), 1 descendant of its own
- K243270: TigerConnect Alarm Management (2025), 0 descendants of its own

## Indications for use
The intended use of the Ascom Unite Connect for Clinical Systems 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, Connect for Clinical Systems is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. Connect for Clinical Systems 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. Connect for Clinical Systems 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/K180566
Methodology: https://510kreport.com/methodology