# K140312: EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM System

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jun 13, 2014 after 126 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K000126 (2000). 22 ancestors in all.
52 later devices descend from it; 3 cite it directly.
1 of 75 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122381: Nexfin Model 2, Edwards Lifesciences, LLC (2013) Summary page 1.
- K110597: EV1000 Clinical Platform, Edwards Lifesciences (2011) Summary page 1.

## Most influential descendants
- 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
- 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

## Recalls of this device
- May 18, 2015 · Class II · Z-1732-2015: Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.

## Indications for use
The EVII 000 Clinical Platform and the ClearSighTM 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. 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 ClearSight TM finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

Source page: https://510kreport.com/device/K140312
Methodology: https://510kreport.com/methodology