Cleared Traditional

K040287 - VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR

K040287 is an FDA 510(k) clearance for VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXI..., 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 80-day FDA review.

K040287 · Edwards Lifesciences, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
80d
Days
Class 2
Risk

K040287 is an FDA 510(k) clearance for the VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME .... 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 April 26, 2004 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Edwards Lifesciences, LLC devices

FDA 510(k) Submission Details - K040287

510(k) Number K040287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2004
Decision Date April 26, 2004
Days to Decision 80 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
45d faster than avg
Panel avg: 125d · This submission: 80d
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 K040287.
EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER
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NICOM
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K032997 · Mennen Medical , Ltd. · Oct 2003
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K010049 · Lidco, Ltd. · Jun 2001