Cleared Traditional

JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT (K925469) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K925469 · J.J. Skinner, Inc. · Gastroenterology & Urology device
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May 1995
Decision
916d
Days
Class 1
Risk

K925469 is an FDA 510(k) clearance for the JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT. Classified as Tray, Start/stop (including Contents), Dialysis (product code FKG), Class I - General Controls.

Submitted by J.J. Skinner, Inc. (Great Neck, US). The FDA issued a Cleared decision on May 3, 1995 after a review of 916 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all J.J. Skinner, Inc. devices

Submission Details

510(k) Number K925469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1992
Decision Date May 03, 1995
Days to Decision 916 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
786d slower than avg
Panel avg: 130d · This submission: 916d
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.