510(k) · Cleared
Recalled · Class II · 2015Ascom Mobile Monitoring Gateway (MMG)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascom (Sweden) AB · MSX System, Network And Communication, Physiological Monitors
Cleared on Jul 5, 2011 as substantially equivalent to K103634 (Ascom (Us), Inc., 2011) after a 64-day review. Its family tree reaches back 6 generations to 1997. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 5, 2011
- Review
- 64 days
- Class
- Class II
- Product code
- MSX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K962827 (1997). 7 ancestors in all, the oldest K945277 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK962827 Alarm Display Unit/Pager-Lan System (Adu)Marquette Electronics, Inc. · 1997
- 5 generations backK971868 Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMarquette Electronics, Inc. · 1997
- 4 generations backK973527 Cardio-Pager SystemData Critical Corp. · 1998
- 3 generations backK992749 Ultraview Waveform Pager System, Model 91841Spacelabs Medical, Inc. · 2000
- 2 generations backK062278 Spacelabs Medical Clinical Event Interface, Model 91847Spacelabs Medical, Inc. · 2006
- 1 generation backK103634 Ascom Clinicalconnex CardiomaxAscom (Us), Inc. · 2011
- This deviceK111215 Ascom Mobile Monitoring Gateway (MMG)Ascom (Sweden) AB · 2011
- Descendant · cites it directly · 2 of its ownK193421 Smart Alarm InterfaceBoxview, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK243270 TigerConnect Alarm ManagementTigerconnect · 2025
- Descendant · 2 generations on · 0 of its ownK212622 Zyter RPMZyter, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962827 | Alarm Display Unit/Pager-Lan System (Adu) | Marquette Electronics, Inc. | 1997 | — |
| −5 | K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager System | Marquette Electronics, Inc. | 1997 | — |
| −4 | K973527 | Cardio-Pager System | Data Critical Corp. | 1998 | — |
| −3 | K992749 | Ultraview Waveform Pager System, Model 91841 | Spacelabs Medical, Inc. | 2000 | — |
| −2 | K062278 | Spacelabs Medical Clinical Event Interface, Model 91847 | Spacelabs Medical, Inc. | 2006 | — |
| −1 | K103634 | Ascom Clinicalconnex Cardiomax | Ascom (Us), Inc. | 2011 | — |
| 0 (this device) | K111215 | Ascom Mobile Monitoring Gateway (MMG) | Ascom (Sweden) AB | 2011 | — |
| +1 | K193421 | Smart Alarm Interface | Boxview, LLC | 2020 | — |
| +2 | K243270 | TigerConnect Alarm Management | Tigerconnect | 2025 | — |
| +2 | K212622 | Zyter RPM | Zyter, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSX device
- #1 K242750 Central Stationscore 21.5 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103634 | Ascom Clinicalconnex CardiomaxSummary page 1…odel Predicate 510(k) PredicateManufacturer Equivalent Devices: Number and Model Ascom Mobile K103634 Ascomn Cardiomax Monitoring Gateway (MMG)… | 2011 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193421 | Smart Alarm Interface | 2020 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 10, 2015 | Class II | Z-1638-2016 | Software design | 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 from GE Carescape/Nurse Call will not… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K193421 (Boxview, LLC, 2020) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K103634.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
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…
Read the full statement (143 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111215: Ascom Mobile Monitoring Gateway (MMG).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111215
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026