Cleared Traditional

ACUTE RENAL DIALYSIS TRAY (K790353) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K790353 · Argon Medical Corp. · Gastroenterology & Urology device
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Apr 1979
Decision
57d
Days
Class 1
Risk

K790353 is an FDA 510(k) clearance for the ACUTE RENAL DIALYSIS TRAY. Classified as Tray, Start/stop (including Contents), Dialysis (product code FKG), Class I - General Controls.

Submitted by Argon Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on April 20, 1979 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology device 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 K790353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1979
Decision Date April 20, 1979
Days to Decision 57 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 130d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FKG Tray, Start/stop (including Contents), Dialysis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.