510(k) · Cleared
ClearedAlarmview 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 Nov 19, 1999 after an 87-day review. The FDA summary names its predicate without a number.
- Decided
- Nov 19, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (4)
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 |
|---|---|---|---|
| * | — | StatView™ System by Data Critical Corporation Named without a submission number | |
| * | — | TS2000 by Trincore Systems Named without a submission number | |
| * | — | Pager-LAN by GE Marquette Medical Systems Named without a submission number | |
| * | — | “Paging” by Vitalcom Named without a submission number |
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.
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?
This device is intended 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. It is intended to be a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers. AlarmView is limited to use by qualified medical professionals who have been trained on the use of the device. It is…
Read the full statement (139 words)
This device is intended 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. It is intended to be a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers.
AlarmView 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.
AlarmView is intended to supplement and not to replace any part of the current device monitoring procedures.
AlarmView is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.
AlarmView is currently validated for use with the N-x9y and N-3x00 data protocols.
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/K992848 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992848: Alarmview System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992848
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026