Cleared Traditional

EnteraLoc Flow (K210971) - FDA 510(k) Clearance

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

K210971 · Vonco Products · Gastroenterology & Urology device
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Aug 2021
Decision
140d
Days
Class 2
Risk

K210971 is an FDA 510(k) clearance for the EnteraLoc Flow. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Vonco Products (Trevor, US). The FDA issued a Cleared decision on August 18, 2021 after a review of 140 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. 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.

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Submission Details

510(k) Number K210971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2021
Decision Date August 18, 2021
Days to Decision 140 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
10d slower than avg
Panel avg: 130d · This submission: 140d
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 K210971.
Enteral Feeding Set
K210854 · Kb Medical (Group), Inc. · Nov 2021
Pediatric Nasogastric Feeding Tubes - Single ENFit Port
K210598 · Cair Lgl · Nov 2021
Enteral Extension Sets
K203633 · GBUK Group, Ltd. · 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
Vesco Medical Extension Feeding Set
K192991 · Vesco Medical, LLC · Aug 2020