510(k) · Cleared
ClearedModification to Alarmview Wireless Data Network System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Data Critical Corp. · MSX System, Network And Communication, Physiological Monitors
Cleared on Oct 19, 2001 as substantially equivalent to K012005 (Data Critical Corp., 2001) after a 28-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Oct 19, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010912 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK010912 Alarmview Wireless Data Network SystemData Critical Corp. · 2001
- 1 generation backK012005 Modification to Alarmview Wireless Data Network SystemData Critical Corp. · 2001
- This deviceK013156 Modification to Alarmview Wireless Data Network SystemData Critical Corp. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010912 | Alarmview Wireless Data Network System | Data Critical Corp. | 2001 | — |
| −1 | K012005 | Modification to Alarmview Wireless Data Network System | Data Critical Corp. | 2001 | — |
| 0 (this device) | K013156 | Modification to Alarmview Wireless Data Network System | Data Critical Corp. | 2001 | — |
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 |
|---|---|---|---|
| * | K012005 | Modification to Alarmview Wireless Data Network SystemSummary page 1…ssification System, Network and Communication, Physiological Monitors Name: Device Classification: Class i Predicate Device(s): AlarmView™ Wireless Data Network System K012005 Device Description The modified AlarmView™ Wireless Data Network System is a low powered local area wireless paging system that… | 2001 |
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 0 years and passes through 1 company; a new generation was cleared every 4 months on median.
- None of the 2 ancestors has a recall.
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.
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 AlarmView™ Wireless Data Network System is for use in real-time monitoring of routine patient status and alarm events on medical devices. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. The AlarmView™ System provides a secondary means of annunciating and displaying patient alarm information to mobile healthcare professionals. The AlarmView™ System is limited to use by qualified medical professionals who…
Read the full statement (132 words)
The AlarmView™ Wireless Data Network System is for use in real-time monitoring of routine patient status and alarm events on medical devices. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. The AlarmView™ System provides a secondary means of annunciating and displaying patient alarm information to mobile healthcare professionals.
The AlarmView™ System is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use in hospital and hospital type environments and is not for home use.
The AlarmView™ System is to supplement and not replace any part of the current device monitoring procedure.
The AlarmView™ System is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician’s care.
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/K013156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013156: Modification to Alarmview Wireless Data Network System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013156
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026