# K182245: EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Nov 30, 2018 after 102 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: 11 generations back to K000126 (2000). 25 ancestors in all.
30 later devices descend from it; 2 cite it directly.
1 of 56 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 4.
- K140312: EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM System, Edwards Lifesciences, LLC (2014) Summary page 4.

## Most influential descendants
- K201446: HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module (2020), 27 descendants of its own
- K203687: HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index (2021), 18 descendants of its own
- K211465: HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform (2021), 15 descendants of its own
- K213682: HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote (2022), 14 descendants of its own
- K223865: HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor (2023), 7 descendants of its own

## Indications for use
The EV1000 Clinical Platform NI and the ClearSightTM 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 non-invasive system is indicated or use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 Clinical Platform and the ClearSightTM Finger Cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

Source page: https://510kreport.com/device/K182245
Methodology: https://510kreport.com/methodology