Cleared Traditional

K915439 - NASOGASTRIC FEEDING TUBE KITS

K915439 is an FDA 510(k) clearance for NASOGASTRIC FEEDING TUBE KITS, 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 85-day FDA review.

K915439 · Sandoz Nutrition · Gastroenterology & Urology device
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Feb 1992
Decision
85d
Days
Class 2
Risk

K915439 is an FDA 510(k) clearance for the NASOGASTRIC FEEDING TUBE KITS. 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 25, 1992 after a review of 85 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 - K915439

510(k) Number K915439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received December 02, 1991
Decision Date February 25, 1992
Days to Decision 85 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 131d · This submission: 85d
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 43
Devices cleared under the same product code (FPD) and FDA review panel - the closest regulatory comparables to K915439.
PEG GASTROSTOMY TUBE KIT
K915308 · Sandoz Nutrition · Mar 1993
NASOJEJUNAL FEEDING TUBE W/GASTRIC DRAINAGE
K913407 · Sandoz Nutrition · Feb 1992
GASTROINTESTINAL TUBE AND ACCESSORIES
K914492 · Sandoz Nutrition · Feb 1992
FEEDING TUBE Y-PORT CONNECTOR
K915438 · Sandoz Nutrition · Feb 1992
STOMA MEASURING DEVICE
K914482 · Biosearch Medical Products, Inc. · Dec 1991
EXTERNAL GASTROSTOMY TUBE RETAINER
K912575 · Sandoz Nutrition · Nov 1991