Cleared Traditional

DIALYIS START CARE KIT (K802361) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K802361 · Med-Pak Corp. · Gastroenterology & Urology device
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Jan 1981
Decision
112d
Days
Class 1
Risk

K802361 is an FDA 510(k) clearance for the DIALYIS START CARE KIT. Classified as Tray, Start/stop (including Contents), Dialysis (product code FKG), Class I - General Controls.

Submitted by Med-Pak Corp. (Mchenry, US). The FDA issued a Cleared decision on January 16, 1981 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K802361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1980
Decision Date January 16, 1981
Days to Decision 112 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
18d faster than avg
Panel avg: 130d · This submission: 112d
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.