# K100709: EV1000 Platform Model: EV1000A, EV1000DB, EV1000M

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Dec 7, 2010 after 270 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). 3 ancestors in all.
55 later devices descend from it; 1 cites 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)
- 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
- 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
- K163381: HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable (2017), 41 descendants of its own

## Indications for use
The EV 1000 Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs constant or intermittent assessment. The EVI1000 Platform may be used in all settings in which critical care is provided.

Source page: https://510kreport.com/device/K100709
Methodology: https://510kreport.com/methodology