# K160552: EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jun 1, 2016 after 93 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K000126 (2000). 24 ancestors in all.
51 later devices descend from it; 9 cite it directly.
1 of 76 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131892: EV1000 Clinical Platform, Edwards Lifesciences, LLC (2014) 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
- 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
- K190205: HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module (2019), 34 descendants of its own
- K182245: EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System (2018), 30 descendants of its own
- K190130: The ClearSight finger cuffs (2019), 29 descendants of its own

## Recalls of this device
- Mar 21, 2019 · Class I · Z-1193-2019: Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.

## 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 for 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. 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. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. 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.

Source page: https://510kreport.com/device/K160552
Methodology: https://510kreport.com/methodology