# K103094: Vigileo Arterial Pressure Cardiac Output / Oximetry Monitor; Vigileo Apco / Oximetry Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: May 17, 2011 after 210 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: 2 generations back to K062134 (2006). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082308: Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor, Edwards Lifesciences, LLC (2008) Summary page 1.

## Most influential descendants
- K131588: Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor; Vigileo Apco/Oximetry Monitor (2014), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K103094
Methodology: https://510kreport.com/methodology