Cleared Traditional

K151503 - NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE

K151503 is an FDA 510(k) clearance for NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE, manufactured by Gbuk Enteral Limited. The device is a Class 2 Gastroenterology & Urology device with product code PIF cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K151503 · Gbuk Enteral Limited · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
306d
Days
Class 2
Risk

K151503 is an FDA 510(k) clearance for the NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Gbuk Enteral Limited (Selby, GB). The FDA issued a Cleared decision on April 5, 2016 after a review of 306 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 Gbuk Enteral Limited devices

FDA 510(k) Submission Details - K151503

510(k) Number K151503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2015
Decision Date April 05, 2016
Days to Decision 306 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
176d slower than avg
Panel avg: 130d · This submission: 306d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - PIF Gastrointestinal Tubes With Enteral Specific Connectors

All 37
Devices cleared under the same product code (PIF) and FDA review panel - the closest regulatory comparables to K151503.
CONOD Enteral Feeding Sets
K181276 · Conod Medical Co., Limited · Jul 2018
Medline ENFit Syringe
K160642 · Medline Industries, Inc. · Nov 2016
EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector
K161003 · Boston Scientific Corporation · Jun 2016
Salem Sump Dual Lumen Stomach Tube with Multi-functional Port
K150711 · Covidien · Oct 2015
Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector
K150084 · Covidien · Jul 2015
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
K150679 · Boston Scientific Corp · May 2015