# K103634: Ascom Clinicalconnex  Cardiomax

- Pathway: 510(k) (Traditional)
- Applicant: Ascom (Us), Inc.
- Decided: Feb 23, 2011 after 72 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: 5 generations back to K962827 (1997). 6 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062278: Spacelabs Medical Clinical Event Interface, Model 91847, Spacelabs Medical, Inc. (2006) Summary page 1.
- (no number) Spacelabs Medical Clinical Event Interface (CEI), Model 91847: named in the summary without a submission number

## Most influential descendants
- K130339: Clinical Alert Notification (2013), 5 descendants of its own
- K152341: ViSi Mobile Monitoring System (2015), 4 descendants of its own
- K111215: Ascom Mobile Monitoring Gateway (MMG) (2011), 3 descendants of its own
- K193421: Smart Alarm Interface (2020), 2 descendants of its own
- K172586: Vios Monitoring System™ Model 2050 (2018), 2 descendants of its own

## Indications for use
The intended use of the Ascom ClinicalConneX | Cardiomax (Cardiomax) 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 Ascom Cardiomax is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. Ascom Cardiomax 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 Ascom Cardiomax 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/K103634
Methodology: https://510kreport.com/methodology