Cleared Traditional

K914492 - GASTROINTESTINAL TUBE AND ACCESSORIES

K914492 is an FDA 510(k) clearance for GASTROINTESTINAL TUBE AND ACCESSORIES, 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 140-day FDA review.

K914492 · Sandoz Nutrition · Gastroenterology & Urology device
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Feb 1992
Decision
140d
Days
Class 2
Risk

K914492 is an FDA 510(k) clearance for the GASTROINTESTINAL TUBE AND ACCESSORIES. 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 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.

View all Sandoz Nutrition devices

FDA 510(k) Submission Details - K914492

510(k) Number K914492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received October 08, 1991
Decision Date February 25, 1992
Days to Decision 140 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
10d slower than avg
Panel avg: 130d · This submission: 140d
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 K914492.
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