510(k) · Cleared
ClearedVigileo Arterial Pressure Cardiac Output/Oximetry Monitor; Vigileo Apco/Oximetry Monitor
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 May 22, 2014 as substantially equivalent to K103094 (Edwards Lifesciences, LLC, 2011) after a 356-day review. Its family tree reaches back 3 generations to 2006.
- Decided
- May 22, 2014
- Review
- 356 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K062134 (2006). No later device cites it as a predicate yet.
- Root · 3 generations backK062134 Vigileo Arterial Pressure Cardiac Output/Oximetry MonitorEdwards Lifesciences, LLC · 2006
- 2 generations backK082308 Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry…Edwards Lifesciences, LLC · 2008
- 1 generation backK103094 Vigileo Arterial Pressure Cardiac Output / Oximetry Monitor; Vigileo…Edwards Lifesciences, LLC · 2011
- This deviceK131588 Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor; Vigileo…Edwards Lifesciences, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K062134 | Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor | Edwards Lifesciences, LLC | 2006 | — |
| −2 | K082308 | Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor | Edwards Lifesciences, LLC | 2008 | — |
| −1 | K103094 | Vigileo Arterial Pressure Cardiac Output / Oximetry Monitor; Vigileo Apco /… | Edwards Lifesciences, LLC | 2011 | — |
| 0 (this device) | K131588 | Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor; Vigileo… | Edwards Lifesciences, LLC | 2014 | — |
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 |
|---|---|---|---|
| * | K103094 | Vigileo Arterial Pressure Cardiac Output / Oximetry Monitor; Vigileo Apco / Oximetry…Summary page 1…e (21 CFR 870.1435, product codes DXG, DQE) Regulation Class/ Class III Product Code DXC, DQE Predicate Device K 103094 (cleared 17 March 2011), Edwards Lifesciences, VigileoTM Arterial Pressure Cardiac Output/Oximetry Mo… | 2011 |
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 8 years and passes through 1 company; a new generation was cleared every 2.4 years on median.
- None of the 3 ancestors has a recall.
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. 2014, this device’s year, is highlighted.
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 VigileoTM APCO/Oximetry Monitor is indicated for continuously measuring hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics.
The monitor also displays parameters, such as stroke volume and stroke volume variation, used to assess fluid status and vascular resistance. The VigileoTNi APCO/Oximetry Monitor may be used in all settings in which critical care is provided.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131588: Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor; Vigileo Apco/Oximetry Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131588
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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