510(k) · Cleared
ClearedAmcom Commtech Messenger
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amcom Software,Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Sep 13, 2011 as substantially equivalent to K102974 (Philips Medical Systems, 2011) after a 57-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Sep 13, 2011
- Review
- 57 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K962827 (1997). 8 ancestors in all, the oldest K945277 (1995). No later device cites it as a predicate yet.
- 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 backK102974 Intellisphere Event Managment System Rel. 10.00Philips Medical Systems · 2011
- This deviceK112047 Amcom Commtech MessengerAmcom Software,Inc. · 2011
View 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 | K102974 | Intellisphere Event Managment System Rel. 10.00 | Philips Medical Systems | 2011 | — |
| 0 (this device) | K112047 | Amcom Commtech Messenger | Amcom Software,Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K102974 | Intellisphere Event Managment System Rel. 10.00 | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
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 8 ancestors has a recall.
- 3 other devices also cite its predicate K102974.
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 intended use of the AmcomTM Commtech MessengerTM (Messenger) 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, Messenger is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. Messenger does not alter the behavior of the primary medical…
Read the full statement (107 words)
The intended use of the AmcomTM Commtech MessengerTM (Messenger) 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, Messenger is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. Messenger 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.
Messenger is intended for use as a secondary alarm. It does not replace the primary alarm function on the monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112047: Amcom Commtech Messenger.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112047
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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