# K111215: Ascom Mobile Monitoring Gateway (MMG)

- Pathway: 510(k) (Traditional)
- Applicant: Ascom (Sweden) AB
- Decided: Jul 5, 2011 after 64 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 1 (0 Class I)
- 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.
3 later devices descend 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)
- K103634: Ascom Clinicalconnex  Cardiomax, Ascom (Us), Inc. (2011) Summary page 1.

## Most influential descendants
- K193421: Smart Alarm Interface (2020), 2 descendants of its own
- K243270: TigerConnect Alarm Management (2025), 0 descendants of its own
- K212622: Zyter RPM (2022), 0 descendants of its own

## Recalls of this device
- Dec 10, 2015 · Class II · Z-1638-2016: Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a software upgrade to one of the other affected versions. Messages f

## Indications for use
The Ascom Mobile Monitoring Gateway (MMG) is intended to interface with the GE Healthcare patient monitoring network and the Ascom Messaging System, in order to provide a secondary means of automated visual and/or audible annunciating and displaying of patient alarm information to healthcare professionals, via display devices. The MMG does not alter the behaviour of the monitoring system. Neither is it intended to replace or alter the primary alarm function on the patient monitor. The MMG is not intended to be used for diagnostic purposes. The MMG is intended for use by professional clinical personnel and relies on proper use and operation of both the communication infrastructure in place at the healthcare facility and the display devices used. The MMG software is installed on specified hardware located in a computer hall or similar, where the MMG can't come into physical contact with patients.

Source page: https://510kreport.com/device/K111215
Methodology: https://510kreport.com/methodology