510(k) · Cleared
ClearedAscom Clinicalconnex Cardiomax
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascom (Us), Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Feb 23, 2011 as substantially equivalent to K062278 (Spacelabs Medical, Inc., 2006) after a 72-day review. Its family tree reaches back 5 generations to 1997. 14 later devices descend from it.
- Decided
- Feb 23, 2011
- Review
- 72 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K962827 (1997). 6 ancestors in all, the oldest K945277 (1995). 14 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK962827 Alarm Display Unit/Pager-Lan System (Adu)Marquette Electronics, Inc. · 1997
- 4 generations backK971868 Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMarquette Electronics, Inc. · 1997
- 3 generations backK973527 Cardio-Pager SystemData Critical Corp. · 1998
- 2 generations backK992749 Ultraview Waveform Pager System, Model 91841Spacelabs Medical, Inc. · 2000
- 1 generation backK062278 Spacelabs Medical Clinical Event Interface, Model 91847Spacelabs Medical, Inc. · 2006
- This deviceK103634 Ascom Clinicalconnex CardiomaxAscom (Us), Inc. · 2011
- Descendant · cites it directly · 5 of its ownK130339 Clinical Alert NotificationExtension, Inc. · 2013
- Descendant · 2 generations on · 4 of its ownK152341 ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK111215 Ascom Mobile Monitoring Gateway (MMG)Ascom (Sweden) AB · 2011 · Recalled
- Descendant · 2 generations on · 2 of its ownK193421 Smart Alarm InterfaceBoxview, LLC · 2020
- Descendant · 3 generations on · 2 of its ownK172586 Vios Monitoring System™ Model 2050Vios Medical, Inc. · 2018 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K130339Clinical Alert NotificationExtension, Inc. · 2013 · cites it directly5descendants
- K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2015 · 2 generations on4descendants
- K111215Ascom Mobile Monitoring Gateway (MMG)Ascom (Sweden) AB · 2011 · cites it directly3descendants
- K193421Smart Alarm InterfaceBoxview, LLC · 2020 · 2 generations on2descendants
- K172586Vios Monitoring System™ Model 2050Vios Medical, Inc. · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962827 | Alarm Display Unit/Pager-Lan System (Adu) | Marquette Electronics, Inc. | 1997 | — |
| −4 | K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager System | Marquette Electronics, Inc. | 1997 | — |
| −3 | K973527 | Cardio-Pager System | Data Critical Corp. | 1998 | — |
| −2 | K992749 | Ultraview Waveform Pager System, Model 91841 | Spacelabs Medical, Inc. | 2000 | — |
| −1 | K062278 | Spacelabs Medical Clinical Event Interface, Model 91847 | Spacelabs Medical, Inc. | 2006 | — |
| 0 (this device) | K103634 | Ascom Clinicalconnex Cardiomax | Ascom (Us), Inc. | 2011 | — |
| +1 | K130339 | Clinical Alert Notification | Extension, Inc. | 2013 | — |
| +2 | K152341 | ViSi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
| +1 | K111215 | Ascom Mobile Monitoring Gateway (MMG) | Ascom (Sweden) AB | 2011 | 1 |
| +2 | K193421 | Smart Alarm Interface | Boxview, LLC | 2020 | — |
| +3 | K172586 | Vios Monitoring System™ Model 2050 | Vios Medical, Inc. | 2018 | 4 |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 4 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K062278 | Spacelabs Medical Clinical Event Interface, Model 91847Summary page 1…ication Middleware Y1030 24 Zail FEB 2 3 System, Network And Communication, Physiological Monitors 21 CFR §870.2300 MSX Ascom Model Predicate 510(k) Number Ascom K062278 ClinicalConneX | Cardiomax Predicate Manufacturer and Model Spacelabs Medical, Inc. / Spacelabs Medical Clinical Event Interf… | 2006 |
| * | — | Spacelabs Medical Clinical Event Interface (CEI), Model 91847 Named without a submission number |
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K130339 (Extension, Inc., 2013) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K062278.
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 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…
Read the full statement (113 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K103634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103634: Ascom Clinicalconnex Cardiomax.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103634
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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