510(k) · Cleared
Recalled · Class II · 2015Modification to: Argus System-Continuous Expert Care Network W/Smart Alrams
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visicu, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Jul 24, 2001 after a 12-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 24, 2001
- Review
- 12 days
- Class
- Class II
- Product code
- MSX
- Recalls
- 2
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK012171 Modification to: Argus System-Continuous Expert Care Network W/Smart…Visicu, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK153156 eCareManager 4.0.1Visicu, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK171322 eCareManager 4.1Visicu, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK211046 eCareManager 4.5Visicu, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK210160 AlertWatch:ACAlertwatch, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK130234 Nuvon Vitals Charting SystemNuvon, Inc. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K153156eCareManager 4.0.1Visicu, Inc. · 2016 · cites it directly3descendants
- K171322eCareManager 4.1Visicu, Inc. · 2017 · 2 generations on2descendants
- K211046eCareManager 4.5Visicu, Inc. · 2022 · 3 generations on0descendants
- K210160AlertWatch:ACAlertwatch, Inc. · 2021 · 3 generations on0descendants
- K130234Nuvon Vitals Charting SystemNuvon, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012171 | Modification to: Argus System-Continuous Expert Care Network W/Smart Alrams | Visicu, Inc. | 2001 | — |
| +1 | K153156 | eCareManager 4.0.1 | Visicu, Inc. | 2016 | — |
| +2 | K171322 | eCareManager 4.1 | Visicu, Inc. | 2017 | — |
| +3 | K211046 | eCareManager 4.5 | Visicu, Inc. | 2022 | — |
| +3 | K210160 | AlertWatch:AC | Alertwatch, Inc. | 2021 | — |
| +1 | K130234 | Nuvon Vitals Charting System | Nuvon, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 27, 2015 | Class II | Z-0399-2016 | Software design | A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen function, the previously selected medication is replaced with… |
| Feb 22, 2012 | Not classified | Z-1474-2012 | Software change control | Three versions of software for the eCareManager failed to display anticoagulants on the medications screen. The problem arose due to an unexpected change in the National Drug Data File. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K153156 (Visicu, Inc., 2016) has gone furthest, with 3 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?
The VISICU ARGUS System is intended for use in data coliection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks.
The VISICU ARGUS System is intended to provide patient " information and surveillance _of monitored patients at the point of care location and at a remote supplementary care location through wide area networking technology and dedicated telephone lines.
The VISICU ARGUS System is solely intended for use ina hqspital environment. It is not intended to be used in a home environment.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012171: Modification to: Argus System-Continuous Expert Care Network W/Smart Alrams.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012171
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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