Cleared Special

K190414 - Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV

K190414 is an FDA 510(k) clearance for Moss Gastrostomy Tube, manufactured by Moss Tubes, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code PIF cleared through the Special 510(k) pathway after a 113-day FDA review.

K190414 · Moss Tubes, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
113d
Days
Class 2
Risk

K190414 is an FDA 510(k) clearance for the Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Moss Tubes, Inc. (Castleton On Hudson, US). The FDA issued a Cleared decision on June 14, 2019 after a review of 113 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K190414

510(k) Number K190414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2019
Decision Date June 14, 2019
Days to Decision 113 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 131d · This submission: 113d
Pathway characteristics
Modification to existing cleared device.

PIF Device Classification - Class 2, Special Controls

Product Code PIF Gastrointestinal Tubes With Enteral Specific Connectors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition To Facilitate Enteral Specific Connections.
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 Consultant

Xeridiem Medical Devices
Meghan McGovern

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 - PIF Gastrointestinal Tubes With Enteral Specific Connectors

All 51
Devices cleared under the same product code (PIF) and FDA review panel - the closest regulatory comparables to K190414.
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U Deliver Bolink ENFit Enteral Feeding Sets
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Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
K181787 · Cedic S.R.L. · Apr 2019
ENConnect 40 mm Screw Cap to ENPlus Adapter
K190327 · Cedic S.R.L. · Apr 2019
K190414 · Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV
Download PDF FDA Summary Moss Tubes, Inc.