Cleared Traditional

K000664 - VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2...

K000664 is the FDA 510(k) clearance for VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2... by Baxter Healthcare Corp. It is a Class 2 Cardiovascular device (product code DXG) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K000664 · Baxter Healthcare Corp · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2000
Decision
205d
Days
Class 2
Risk

K000664 is an FDA 510(k) clearance for the VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on September 20, 2000 after a review of 205 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K000664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2000
Decision Date September 20, 2000
Days to Decision 205 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
80d slower than avg
Panel avg: 125d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 81
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K000664.
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K040287 · Edwards Lifesciences, LLC · Apr 2004
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K991775 · Mennen Medical, Inc. · Jun 1999
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K970784 · Alexander Mfg. Co. · May 1997
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K961661 · Abbott Laboratories · Mar 1997