# K203131: EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jan 22, 2021 after 95 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 27 generations back to K941811 (1994). 243 ancestors in all.
No later device cites it as a predicate yet.
1 of 244 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160552: EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform, Edwards Lifesciences, LLC (2016) Summary page 5.
- K201446: HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module, Edwards Lifesiences, LLC (2020) Summary page 5.
- K183646: Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure, Edwards Lifeciences, LLC (2019) Summary page 5.
- K190205: HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module, Edwards Lifesciences, LLC (2019) Summary page 5.
- K180881: HemoSphere Advanced Monitor, HemoSphere Pressure Cable, Edwards Lifesciences, LLC (2018) Summary page 5.

## 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. Monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol enables consistent fluid management in the intended patient populations. 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 EV1000 Clinical Platform may be used in all settings in which critical care is provided. The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient’s likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient’s physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter. The EV1000 Clinical Platform NI and the ClearSight finger cuffs are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. In addition, the noninvasive system is indicated for use in patients with comorbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 Clinical Platform NI and the ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

Source page: https://510kreport.com/device/K203131
Methodology: https://510kreport.com/methodology