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 17, 2011 as substantially equivalent to K082308 (Edwards Lifesciences, LLC, 2008) after a 210-day review. Its family tree reaches back 2 generations to 2006. 1 later device descends from it.
- Decided
- May 17, 2011
- Review
- 210 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K062134 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK062134 Vigileo Arterial Pressure Cardiac Output/Oximetry MonitorEdwards Lifesciences, LLC · 2006
- 1 generation backK082308 Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry…Edwards Lifesciences, LLC · 2008
- This deviceK103094 Vigileo Arterial Pressure Cardiac Output / Oximetry Monitor; Vigileo…Edwards Lifesciences, LLC · 2011
- Descendant · cites it directly · 0 of its ownK131588 Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor; Vigileo…Edwards Lifesciences, LLC · 2014
Most influential descendants
Showing 1 of 1 · See all- K131588Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor; Vigileo Apco/Oximetry MonitorEdwards Lifesciences, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K062134 | Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor | Edwards Lifesciences, LLC | 2006 | — |
| −1 | K082308 | Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor | Edwards Lifesciences, LLC | 2008 | — |
| 0 (this device) | K103094 | Vigileo Arterial Pressure Cardiac Output / Oximetry Monitor; Vigileo Apco /… | Edwards Lifesciences, LLC | 2011 | — |
| +1 | K131588 | Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor; Vigileo… | Edwards Lifesciences, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 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 |
|---|---|---|---|
| * | K082308 | Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry MonitorSummary page 1…on, Preprogrammed Diagnostic Computer Ne: (21 CFR 870. 1435) Regulation Class/ Class II/ Product Code DXG, DQE Predicate K082308, Edwards Lifesciences LLC, Vigileo Arterial Pressure Devices: Cardiac Output/Oximetry Monitor Device… | 2008 |
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 |
|---|---|---|---|
| K131588 | Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor; Vigileo Apco/Oximetry Monitor | 2014 | 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?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 2.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K131588 (Edwards Lifesciences, LLC, 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K082308.
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. 2011, 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 Vigileo 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 Vigileo APCO/Oximetry Monitor may be used in all setting in which critical care is provided.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103094: 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/K103094
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