# K060660: EW200 System (Oxygen Saturation Monitoring System) and Presep Oximetry Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Apr 25, 2006 after 43 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume (CCO/SvO2/CEDV) Monitor: named in the summary without a submission number
- (no number) 3M CDI Blood Parameter Monitoring System 500: named in the summary without a submission number
- (no number) Central Venous Oximetry Probe Catheter and Probe: named in the summary without a submission number
- (no number) Multi-Med Multi-Lumen Central Venous Catheter: named in the summary without a submission number
- (no number) Edslab Dual Lumen Regional Saturation Oximetry Catheter: named in the summary without a submission number

## Recalls of this device
- Jun 25, 2010 · Not classified · Z-0160-2011: The recall was initiated because the Edwards' MHANM8 Pressure Slave Cable was wired incorrectly, thus will not work as stated.

## Indications for use
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.

Source page: https://510kreport.com/device/K060660
Methodology: https://510kreport.com/methodology