# K082308: Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Dec 9, 2008 after 118 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: 1 generation back to K062134 (2006). 1 ancestor in all.
59 later devices descend from it; 4 cite it directly.
1 of 61 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062134: Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor, Edwards Lifesciences, LLC (2006) Summary page 1.

## Most influential descendants
- K100709: EV1000 Platform Model: EV1000A, EV1000DB, EV1000M (2010), 55 descendants of its own
- K110597: EV1000 Clinical Platform (2011), 54 descendants of its own
- K140312: EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM System (2014), 52 descendants of its own
- K131892: EV1000 Clinical Platform (2014), 52 descendants of its own
- K160552: EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform (2016), 51 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.

Source page: https://510kreport.com/device/K082308
Methodology: https://510kreport.com/methodology