Cleared Traditional

K981629 - NUTRISAFE ENTERAL FEEDING TUBE

K981629 is an FDA 510(k) clearance for NUTRISAFE ENTERAL FEEDING TUBE, manufactured by Schiff & Co.. The device is a Class 2 Gastroenterology & Urology device with product code FPD cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K981629 · Schiff & Co. · Gastroenterology & Urology device
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Feb 1999
Decision
273d
Days
Class 2
Risk

K981629 is an FDA 510(k) clearance for the NUTRISAFE ENTERAL FEEDING TUBE. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Schiff & Co. (West Cadwell, US). The FDA issued a Cleared decision on February 4, 1999 after a review of 273 days - an extended review 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: 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 Schiff & Co. devices

FDA 510(k) Submission Details - K981629

510(k) Number K981629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1998
Decision Date February 04, 1999
Days to Decision 273 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
142d slower than avg
Panel avg: 131d · This submission: 273d
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 30
Devices cleared under the same product code (FPD) and FDA review panel - the closest regulatory comparables to K981629.
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
K091340 · Boston Scientific Corp · Jun 2009
NUTRISAFE 2
K060944 · Vygon Corp. · Sep 2006
NUTRISAFE PUR ENTERAL FEEDING TUBE
K003311 · Vygon Corp. · Jan 2002
ROSS ENTERAL FEEDING TUBE
K972437 · Ross Products · Jan 1998
JEJENOSTOMY FEEDING TUBE
K971906 · Boston Scientific Corp · Aug 1997
RUSCH ENTERAL FEEDING TUBE
K963779 · Rusch, Inc. · May 1997