510(k) · Cleared
Recalled · 2008Vigilance II Continuous Cardiac Output/Oximetry/Volumetric Monitor, Model VIG2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Dec 9, 2004 after a 30-day review. The FDA summary names its predicate without a number. 42 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 9, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- DXG
- Recalls
- 2
- Predicates
- 0
42 later devices descend from it, 1 citing it directly.
- This deviceK043103 Vigilance II Continuous Cardiac Output/Oximetry/Volumetric Monitor…Edwards Lifesciences, LLC · 2004
- Descendant · cites it directly · 41 of its ownK163381 HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere…Edwards Lifesciences, LLC · 2017 · Recalled
- Descendant · 2 generations on · 40 of its ownK180881 HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC · 2018
- Descendant · 3 generations on · 34 of its ownK190205 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019
- Descendant · 4 generations on · 27 of its ownK201446 HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC · 2020 · Recalled
- Descendant · 3 generations on · 18 of its ownK203687 HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen…Edwards Lifesciences, LLC · 2021
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K163381HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry CableEdwards Lifesciences, LLC · 2017 · cites it directly41descendants
- K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC · 2018 · 2 generations on40descendants
- K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019 · 3 generations on34descendants
- K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC · 2020 · 4 generations on27descendants
- K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC · 2021 · 3 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043103 | Vigilance II Continuous Cardiac Output/Oximetry/Volumetric Monitor, Model VIG2 | Edwards Lifesciences, LLC | 2004 | — |
| +1 | K163381 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry… | Edwards Lifesciences, LLC | 2017 | 2 |
| +2 | K180881 | HemoSphere Advanced Monitor, HemoSphere Pressure Cable | Edwards Lifesciences, LLC | 2018 | — |
| +3 | K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | Edwards Lifesciences, LLC | 2019 | — |
| +4 | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC | 2020 | 1 |
| +3 | K203687 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension… | Edwards Lifesciences, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 7 | 0 |
| 2022 | 5 | 0 |
| 2023 | 9 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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 DXG? 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 DXG device
- #1 K253092 Argos Infinity (Rev. 1.0)score 11.1 · 2 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 |
|---|---|---|---|
| * | — | Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume… Named without a submission number |
What descends from it? (42)
See all 421 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163381 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable | 2017 | 41 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 12, 2008 | Not classified | Z-0942-2012 | Device Design | Edwards Lifesciences has made the decision to initiate a field corrective action for the Edwards Vigilance II Model: Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73 due to the potential of… |
| May 17, 2007 | Not classified | Z-0262-2008 | Software design | MAP offset errors: If users are "slaving" mean arterial pressure (MAP) from the bedside monitor into the Vigilance II Monitor for the purpose of the continuous calculation of systemic vascular resistance (SVR), at times, on some bedside… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K163381 (Edwards Lifesciences, LLC, 2017) has gone furthest, with 41 descendants of its own.
How does its category compare?
All DXG devicesDXG Computer, Diagnostic, Pre-Programmed, Single-Function: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXG
290in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXG
8in 2025
MAUDE reports naming product code DXG, 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 | 1 | — | 1 | 43 |
| 2008 | 5 | 118 | 1 | 37 |
| 2009 | 0 | — | 6 | 8 |
| 2010 | 4 | 282 | 1 | 17 |
| 2011 | 3 | 104 | 0 | 7 |
| 2012 | 2 | — | 0 | 29 |
| 2013 | 3 | 236 | 0 | 23 |
| 2014 | 6 | 290 | 0 | 44 |
| 2015 | 1 | — | 0 | 34 |
| 2016 | 1 | — | 0 | 67 |
| 2017 | 1 | — | 0 | 62 |
| 2018 | 2 | — | 0 | 83 |
| 2019 | 2 | — | 0 | 81 |
| 2020 | 1 | — | 2 | 49 |
| 2021 | 1 | — | 0 | 29 |
| 2022 | 0 | — | 0 | 44 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Vigilance II CCO/Sv0 2/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry and right ventricular ejection fraction and end diastolic volume measurements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043103: Vigilance II Continuous Cardiac Output/Oximetry/Volumetric Monitor, Model VIG2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043103
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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