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The ClearSight finger cuffs

FDA 510(k)

Class II (US FDA 510(k))

510(k) K190130

by Edwards Lifesciences LLC

Identifiers

510(k) Number
K190130 FDA 510(k)
FDA Product Code
DXN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1130 FDA 510(k)
Regulation Number
870.1130 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ClearSight finger cuffs are a noninvasive device that utilizes the volume-clamp method to measure blood pressure and associated hemodynamic parameters. They consist of an inflatable bladder wrapped around the middle phalanx of the finger and are designed for use with the EV1000 clinical platform NI or HemoSphere advanced monitoring platform as part of the ClearSight system.

The device is supplied non-sterile and is indicated for patients over 18 years of age. It is used in clinical settings to provide continuous blood pressure and advanced hemodynamic data for hemodynamic management. The ClearSight finger cuffs received FDA 510(k) clearance under K190130 and are classified under product code DXN.

Frequently asked questions

What is the ClearSight finger cuffs used for?

The ClearSight finger cuffs are used to measure blood pressure and associated hemodynamic parameters continuously in clinical settings, utilizing the volume-clamp method via an inflatable bladder wrapped around the middle phalanx of the finger for hemodynamic management in patients over 18 years of age.

How are the ClearSight finger cuffs supplied and are they sterile?

The ClearSight finger cuffs are supplied non-sterile and are intended for single-patient use; they are not provided in a sterile condition and must be used as part of the ClearSight system with compatible monitoring platforms such as the EV1000 NI or HemoSphere advanced monitoring platform.

What platforms are the ClearSight finger cuffs compatible with?

The ClearSight finger cuffs are designed for use with the EV1000 clinical platform NI or the HemoSphere advanced monitoring platform as part of the ClearSight system, enabling continuous noninvasive blood pressure and hemodynamic monitoring when integrated with these systems.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ClearSight system | Edwards Lifesciences, PDF ClearSight Finger Cuff - Edwards Lifesciences, PDF Acumen IQ Finger Cuff ClearSight Finger Cuff - eifu.edwards.com, The ClearSight finger cuffs (K190130) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Edwards Lifesciences LLC
FDA Applicant
Edwards Lifesciences, LLC

Sources (1)

  • FDA 510(k) K190130 24 fields · synced Sep 22, 2026