510(k) · Cleared
ClearedModification to Vigileo Arterial Pressure Cardiac Output/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 Dec 9, 2008 as substantially equivalent to K062134 (Edwards Lifesciences, LLC, 2006) after a 118-day review. Its family tree reaches back 1 generation to 2006. 1 of the 61 devices in its family, counting itself, has a Class I recall. 59 later devices descend from it.
- Decided
- Dec 9, 2008
- Review
- 118 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062134 (2006). 59 later devices descend from it, 4 citing it directly. 1 of the 61 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK062134 Vigileo Arterial Pressure Cardiac Output/Oximetry MonitorEdwards Lifesciences, LLC · 2006
- This deviceK082308 Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry…Edwards Lifesciences, LLC · 2008
- Descendant · cites it directly · 55 of its ownK100709 EV1000 Platform Model: EV1000A, EV1000DB, EV1000MEdwards Lifesciences, LLC · 2010
- Descendant · cites it directly · 54 of its ownK110597 EV1000 Clinical PlatformEdwards Lifesciences · 2011
- Descendant · 2 generations on · 52 of its ownK140312 EV1000 Clinical Platform with Clearsight TM Finger Cuff or…Edwards Lifesciences, LLC · 2014 · Recalled
- Descendant · 2 generations on · 52 of its ownK131892 EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2014
- Descendant · 3 generations on · 51 of its ownK160552 EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight…Edwards Lifesciences, LLC · 2016 · Recalled (Class I)
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K160552 EV1000 Clinical Platform with ClearSight Finger…3 generations on · 2016
Most influential descendants
Showing 5 of 59 · See all- K100709EV1000 Platform Model: EV1000A, EV1000DB, EV1000MEdwards Lifesciences, LLC · 2010 · cites it directly55descendants
- K110597EV1000 Clinical PlatformEdwards Lifesciences · 2011 · cites it directly54descendants
- K140312EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM SystemEdwards Lifesciences, LLC · 2014 · 2 generations on52descendants
- K131892EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2014 · 2 generations on52descendants
- K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000…Edwards Lifesciences, LLC · 2016 · 3 generations on51descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062134 | Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor | Edwards Lifesciences, LLC | 2006 | — |
| 0 (this device) | K082308 | Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor | Edwards Lifesciences, LLC | 2008 | — |
| +1 | K100709 | EV1000 Platform Model: EV1000A, EV1000DB, EV1000M | Edwards Lifesciences, LLC | 2010 | — |
| +1 | K110597 | EV1000 Clinical Platform | Edwards Lifesciences | 2011 | — |
| +2 | K140312 | EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM System | Edwards Lifesciences, LLC | 2014 | 1 |
| +2 | K131892 | EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2014 | — |
| +3 | K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System… | Edwards Lifesciences, LLC | 2016 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 4 | 0 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 6 | 0 |
| 2020 | 1 | 0 |
| 2021 | 7 | 0 |
| 2022 | 6 | 0 |
| 2023 | 11 | 0 |
| 2024 | 5 | 0 |
| 2025 | 8 | 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.
1 device in this family has a Class I recall. 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 11.2 · 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 |
|---|---|---|---|
| * | K062134 | Vigileo Arterial Pressure Cardiac Output/Oximetry MonitorSummary page 1…Computer Name: Single-Function, Preprogrammed Diagnostic Computer (21 CFR 870.1435) Predicate Device: Vigileo APCO/Oximetry Monitor: K062134, cleared August 22, 2006 Device The Vigileo APCO/Oximetry Monitor is a microprocessor- Descript… | 2006 |
What descends from it? (59)
See all 594 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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. 2008, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082308 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082308: Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082308
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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