510(k) · Cleared
ClearedStatview 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 Sep 20, 1999 after a 224-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Sep 20, 1999
- Review
- 224 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK990378 Statview SystemData Critical Corp. · 1999
- Descendant · cites it directly · 0 of its ownK112282 M Visum Alert Alarm Management SystemMvisum, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K112282M Visum Alert Alarm Management SystemMvisum, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990378 | Statview System | Data Critical Corp. | 1999 | — |
| +1 | K112282 | M Visum Alert Alarm Management System | Mvisum, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (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 (previously cleared) Named without a submission number | |
| * | — | Pager-LAN Named without a submission number | |
| * | — | Palm Vue (M1490A) Named without a submission number | |
| * | — | “Paging” Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112282 | M Visum Alert Alarm Management System | 2011 | 0 |
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?
- Of its descendants, K112282 (Mvisum, Inc., 2011) has gone furthest, with 0 descendants of its own.
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 indicated for use in real-time monitoring of routine patient status and alarm events. StatView is limited to use by qualified medical professionals who have been trained on the use of the device. StatView is not intended for home use. StatView™ is a paging system that interfaces with primary patient monitoring systems (PPMS) to serve as a parallel, redundant mechanism to inform the clinical staff of patient events. It is intended to be a…
Read the full statement (110 words)
This device is indicated for use in real-time monitoring of routine patient status and alarm events. StatView is limited to use by qualified medical professionals who have been trained on the use of the device. StatView is not intended for home use.
StatView™ is a paging system that interfaces with primary patient monitoring systems (PPMS) to serve 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.
StatView™ has been validated for use with the following networks: Héwlett-Packard CareNet, GE Marquette Medical Unity, and Siemens Medical Systems Infinity.
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/K990378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990378: Statview System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990378
Report an extraction error
Are you the manufacturer?
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