Cleared Traditional

K143177 - KleenGel Dispenser

K143177 is an FDA 510(k) clearance for KleenGel Dispenser, manufactured by Kleengel, LLC. The device is a Class 1 General Hospital device with product code KYX cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K143177 · Kleengel, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K143177

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
185d slower than avg
Panel avg: 129d · This submission: 314d
Pathway characteristics
Predicate-based equivalence.

KYX Device Classification - Class 1, General Controls

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.

Regulatory Consultant

Mdi Consultants, Inc.
Maria Griffin

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KYX Dispenser, Liquid Medication

Devices cleared under the same product code (KYX) and FDA review panel - the closest regulatory comparables to K143177.
CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER
K980109 · Sangstat Medical Corp. · Aug 1998
CANYONS BI-DIRECTIONAL CHECK VALVE
K954181 · Canyon Medical Products · Nov 1995
BOTTLE ADAPTER
K830571 · Burron Medical Products, Inc. · Mar 1983
MULTI-AD FLUID DISPENSING PUMP MP-3000
K801008 · Burron Medical Products, Inc. · Jun 1980
SYRINGE TIP CONNECTOR
K800437 · Burron Medical Products, Inc. · Mar 1980
MULTI-AD FLUID DISPENSING SYSTEM
K792227 · National Patent Development Corp. · Dec 1979