Cleared Traditional

K915438 - FEEDING TUBE Y-PORT CONNECTOR

K915438 is an FDA 510(k) clearance for FEEDING TUBE Y-PORT CONNECTOR, manufactured by Sandoz Nutrition. The device is a Class 2 Gastroenterology & Urology device with product code FPD cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K915438 · Sandoz Nutrition · Gastroenterology & Urology device
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Feb 1992
Decision
84d
Days
Class 2
Risk

K915438 is an FDA 510(k) clearance for the FEEDING TUBE Y-PORT CONNECTOR. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Sandoz Nutrition (Minneapolis, US). The FDA issued a Cleared decision on February 24, 1992 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sandoz Nutrition devices

FDA 510(k) Submission Details - K915438

510(k) Number K915438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1991
Decision Date February 24, 1992
Days to Decision 84 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 130d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPD Device Classification - Class 2, Special Controls

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 20
Devices cleared under the same product code (FPD) and FDA review panel - the closest regulatory comparables to K915438.
NUTRISAFE PUR ENTERAL FEEDING TUBE
K003311 · Vygon Corp. · Jan 2002
JEJENOSTOMY FEEDING TUBE
K971906 · Boston Scientific Corp · Aug 1997
STERILE FEEDING TUBE
K954218 · Baxter Healthcare Corp · Nov 1995
STOMA MEASURING DEVICE
K914482 · Biosearch Medical Products, Inc. · Dec 1991
FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE
K912972 · Abbott Laboratories · Sep 1991
WILSON-COOK PULL THROUGH PEG KIT
K901163 · Wilson-Cook Medical, Inc. · Nov 1990