Cleared Traditional

K140312 - EV1000 CLINICAL PLATFORM WITH CLEARSIGH...

K140312 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 126-day FDA review.

K140312 · Edwards Lifesciences, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
126d
Days
Class 2
Risk

K140312 is an FDA 510(k) clearance for the EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM. 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 13, 2014 after a review of 126 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 - K140312

510(k) Number K140312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2014
Decision Date June 13, 2014
Days to Decision 126 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
1d slower than avg
Panel avg: 125d · This submission: 126d
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

All 565
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K140312.
AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
K133989 · Mortara Instrument, Inc. · Nov 2014
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR
K141083 · Microlife Intellectual Property GmbH · Aug 2014
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K140121 · Andon Health Co, Ltd. · Jul 2014
HEM-7320
K133383 · Omron Healthcare, Inc. · Mar 2014
HEM-7311
K133379 · Omron Healthcare, Inc. · Jan 2014
HEM-6221
K131749 · Omron Healthcare, Inc. · Oct 2013