510(k) · Cleared
Recalled · 2010EW200 System (Oxygen Saturation Monitoring System) and Presep Oximetry Catheter
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 Apr 25, 2006 after a 43-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- Apr 25, 2006
- Review
- 43 days
- Class
- Class II
- Product code
- DXG
- Recalls
- 1
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (5)
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 | |
| * | — | 3M CDI Blood Parameter Monitoring System 500 Named without a submission number | |
| * | — | Central Venous Oximetry Probe Catheter and Probe Named without a submission number | |
| * | — | Multi-Med Multi-Lumen Central Venous Catheter Named without a submission number | |
| * | — | Edslab Dual Lumen Regional Saturation Oximetry Catheter Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 25, 2010 | Not classified | Z-0160-2011 | Process design | The recall was initiated because the Edwards' MHANM8 Pressure Slave Cable was wired incorrectly, thus will not work as stated. |
No ancestor or descendant has a Class I 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.
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 EW200 System is indicated for use in patients requiring monitoring of hemodynamic parameters, including oxygen saturation and hemoglobin.
The PreSep Oximetry catheter is indicated for hemodynamic monitoring through oxygen saturation measurement and hemoglobin measurement.
Edwards oximetry catheters are indicated for oxygen saturation and hemoglobin measurement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060660: EW200 System (Oxygen Saturation Monitoring System) and Presep Oximetry Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060660
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026