Cleared Traditional

VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) (K180236) - FDA 510(k) Clearance

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

K180236 · Vr Medical Technology Co., Ltd. · Gastroenterology & Urology device
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Jan 2019
Decision
354d
Days
Class 2
Risk

K180236 is an FDA 510(k) clearance for the VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES). Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Vr Medical Technology Co., Ltd. (Zhouzhuang, CN). The FDA issued a Cleared decision on January 18, 2019 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Vr Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K180236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2018
Decision Date January 18, 2019
Days to Decision 354 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
224d slower than avg
Panel avg: 130d · This submission: 354d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPD Tube, Feeding
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 - FPD Tube, Feeding

All 58
Devices cleared under the same product code (FPD) and FDA review panel - the closest regulatory comparables to K180236.
Nutrifit
K243361 · Vygon USA · Dec 2024
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
K091340 · Boston Scientific Corp · Jun 2009
JEJENOSTOMY FEEDING TUBE
K971906 · Boston Scientific Corp · Aug 1997
STERILE FEEDING TUBE
K954218 · Baxter Healthcare Corp · Nov 1995
FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE
K912972 · Abbott Laboratories · Sep 1991