Cleared Traditional

K100709 - EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M

K100709 is an FDA 510(k) clearance for EV1000 PLATFORM MODEL: EV1000A, manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K100709 · Edwards Lifesciences, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
270d
Days
Class 2
Risk

K100709 is an FDA 510(k) clearance for the EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on December 7, 2010 after a review of 270 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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 - K100709

510(k) Number K100709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2010
Decision Date December 07, 2010
Days to Decision 270 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
145d slower than avg
Panel avg: 125d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXG Device Classification - Class 2, Special Controls

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 116
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K100709.
PULSIOFLEX
K112448 · Pulsion Medical Systems, Inc. · Sep 2011
EV1000 CLINICAL PLATFORM
K110597 · Edwards Lifesciences · Jun 2011
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR
K103094 · Edwards Lifesciences, LLC · May 2011
CHEETAH NICOM SYSTEM
K101487 · Cheetah Medical, Inc. · Jul 2010
PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)
K091786 · Pulsion Medical Systems AG · Jun 2010
NAVIGATOR CLINICAL GUIDENCE SYSTEM
K092219 · Applied Physiology Pty , Ltd. · May 2010