Cleared Traditional

K904994 - CLOSED SYSTEM FLUSH SET

K904994 is the FDA 510(k) clearance for CLOSED SYSTEM FLUSH SET by Argon Medical Corp.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K904994 · Argon Medical Corp. · Cardiovascular device
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Jan 1991
Decision
69d
Days
Class 2
Risk

K904994 is an FDA 510(k) clearance for the CLOSED SYSTEM FLUSH SET. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Argon Medical Corp. (Athens, US). The FDA issued a Cleared decision on January 15, 1991 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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 Argon Medical Corp. devices

Submission Details

510(k) Number K904994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1990
Decision Date January 15, 1991
Days to Decision 69 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 125d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - DXT Injector And Syringe, Angiographic

All 102
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K904994.
TRAC-WRIGHT SYSTEM, MODEL TW2
K910594 · Dow Corning Wright · Sep 1991
MEDRAD VARIBLE INFUSION INJECTOR
K905819 · Medrad, Inc. · Sep 1991
BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP
K910873 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1991
HIGH-PRESSURE CONNECTOR TUBE
K904212 · Mallinckrodt Medical · Dec 1990
MAINTENACE FLOW - ACCESORY DEVICE FOR CAVROPUMP
K903494 · Life-Tech Intl., Inc. · Oct 1990
LIQUID DETECTOR
K903495 · Life-Tech Intl., Inc. · Oct 1990