# K110597: EV1000 Clinical Platform

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences
- Decided: Jun 14, 2011 after 104 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). 4 ancestors in all.
54 later devices descend from it; 2 cite it directly.
1 of 59 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100709: EV1000 Platform Model: EV1000A, EV1000DB, EV1000M, Edwards Lifesciences, LLC (2010) Summary page 1.
- K082308: Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor, Edwards Lifesciences, LLC (2008) Summary page 1.
- K072735: Pulsion Picco-2, Model 8500, Pulsion Medical Systems AG (2007) Summary page 1.

## Most influential descendants
- 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
- K163381: HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable (2017), 41 descendants of its own
- K180881: HemoSphere Advanced Monitor, HemoSphere Pressure Cable (2018), 40 descendants of its own

## Indications for use
The EV1000 Clinical Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV 1000 Clinical Platform may be used in all settings in which critical care is provided.

Source page: https://510kreport.com/device/K110597
Methodology: https://510kreport.com/methodology