Cleared Traditional

K160552 - EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform

K160552 is an FDA 510(k) clearance for EV1000 Clinical Platform with ClearSigh..., manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K160552 · Edwards Lifesciences, LLC · Cardiovascular device
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Jun 2016
Decision
93d
Days
Class 2
Risk

K160552 is an FDA 510(k) clearance for the EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV.... Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on June 1, 2016 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Edwards Lifesciences, LLC devices

FDA 510(k) Submission Details - K160552

510(k) Number K160552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2016
Decision Date June 01, 2016
Days to Decision 93 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 125d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

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