Cleared Traditional

CAPD PREP KIT (K833780) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K833780 · Professional Dialysis Products · Gastroenterology & Urology device
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Feb 1984
Decision
104d
Days
Class 1
Risk

K833780 is an FDA 510(k) clearance for the CAPD PREP KIT. Classified as Tray, Start/stop (including Contents), Dialysis (product code FKG), Class I - General Controls.

Submitted by Professional Dialysis Products (Mchenry, US). The FDA issued a Cleared decision on February 9, 1984 after a review of 104 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 K833780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1983
Decision Date February 09, 1984
Days to Decision 104 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
26d faster than avg
Panel avg: 130d · This submission: 104d
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.