510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K000664Substantially Equivalent

Vigilance Cco/cedv & Vigilance Cco/svo2/cedv Monitors

Baxter Healthcare Corporation, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000664 is the FDA 510(k) clearance record for VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS, a class II device, cleared for Baxter Healthcare Corp on under FDA product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K000664.

Clearance record

Decision date
Received
(205 days to decision)
Product code
DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Regulation
21 CFR 870.1435
Device class
Class II
Review panel
Cardiovascular
Applicant
Baxter Healthcare Corp 17221 Red Hill Ave., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code DXG

Trailing 12 months
1 clearance under product code DXG in the twelve months to November 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXG, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260