# K180430: Digistat Smart Central

- Pathway: 510(k) (Traditional)
- Applicant: Ascom Ums Srl Unipersonale
- Decided: Nov 23, 2018 after 280 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.
1 later device descends from it; 1 cites it directly.
0 of 9 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 5.

## Most influential descendants
- K261287: Digistat Care (2026), 0 descendants of its own

## Indications for use
The intended use of the Digistat Smart Central is to provide an interface with clinical systems to forward information associated to the particular event from patient monitors, ventilators, and infusion pumps to the designated display device(s). For medical, near real time alarms, the Digistat Smart Central is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. The Digistat Smart Central 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 Digistat Smart Central is intended for use as a secondary alarm. It does not replace the primary alarm function on the medical devices.

Source page: https://510kreport.com/device/K180430
Methodology: https://510kreport.com/methodology