Cleared Traditional

Vesco Medical Extension Feeding Set (K192991) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192991 · Vesco Medical, LLC · Gastroenterology & Urology device
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Aug 2020
Decision
283d
Days
Class 2
Risk

K192991 is an FDA 510(k) clearance for the Vesco Medical Extension Feeding Set. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Vesco Medical, LLC (Columbus, US). The FDA issued a Cleared decision on August 3, 2020 after a review of 283 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vesco Medical, LLC devices

Submission Details

510(k) Number K192991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2019
Decision Date August 03, 2020
Days to Decision 283 days
Submission Type Traditional
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
153d slower than avg
Panel avg: 130d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - PIF Gastrointestinal Tubes With Enteral Specific Connectors

All 36
Devices cleared under the same product code (PIF) and FDA review panel - the closest regulatory comparables to K192991.
EnteraLoc Flow
K210971 · Vonco Products · Aug 2021
Gabriel 3 Way EnFit Valve
K201741 · Syncro Medical Innovations, Inc. · Nov 2020
Nutricare Clear-ISOSAF Nasogastric Feeding Tube
K202357 · Three Circles Consulting Limited · Oct 2020
BD Univia RightFit Enteral Extension Sets and Transitional Adapters
K200082 · Mps Medical, Inc. · Jul 2020
Medline Quick Switch Valve with ENFit Connector
K191759 · Medline Industries, Inc. · Dec 2019
Gabriel Feeding Tube with Balloon, and EnFit Connector
K191784 · Syncro Medical Innovations, Inc. · Nov 2019