Cleared Special

K141631 - AQUARIUS EXTENSION FEEDING SET

K141631 is the FDA 510(k) clearance for AQUARIUS EXTENSION FEEDING SET by Degania Silicone , Ltd.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Special 510(k) pathway after a 40-day FDA review.

K141631 · Degania Silicone , Ltd. · Gastroenterology & Urology device
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Jul 2014
Decision
40d
Days
Class 2
Risk

K141631 is an FDA 510(k) clearance for the AQUARIUS EXTENSION FEEDING SET. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Degania Silicone , Ltd. (Emek Hayarden, IL). The FDA issued a Cleared decision on July 28, 2014 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Degania Silicone , Ltd. devices

Submission Details

510(k) Number K141631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received June 18, 2014
Decision Date July 28, 2014
Days to Decision 40 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 130d · This submission: 40d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 253
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