# K131588: Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor; Vigileo Apco/Oximetry Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: May 22, 2014 after 356 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K062134 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103094: Vigileo Arterial Pressure Cardiac Output / Oximetry Monitor; Vigileo Apco / Oximetry Monitor, Edwards Lifesciences, LLC (2011) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K131588
Methodology: https://510kreport.com/methodology