Cleared Traditional

K143177 - KleenGel Dispenser (FDA 510(k) Clearance)

Class I General Hospital device.

K143177 · Kleengel, LLC · General Hospital
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Sep 2015
Decision
314d
Days
Class 1
Risk

K143177 is an FDA 510(k) clearance for the KleenGel Dispenser. Classified as Dispenser, Liquid Medication (product code KYX), Class I - General Controls.

Submitted by Kleengel, LLC (Boca Raton, US). The FDA issued a Cleared decision on September 14, 2015 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6430 - the FDA general hospital 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K143177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2014
Decision Date September 14, 2015
Days to Decision 314 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 128d · This submission: 314d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYX Dispenser, Liquid Medication
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6430
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.