Cleared Traditional

NUTRISAFE ENTERAL FEEDING TUBE (K981629) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 130d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 9
Devices cleared under the same product code (FPD) and FDA review panel - the closest regulatory comparables to K981629.
INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE
K131590 · Philips Medical Systems · Oct 2013
INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE
K120815 · Philips Medical Systems · Mar 2013
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
K091340 · Boston Scientific Corp · Jun 2009
JEJENOSTOMY FEEDING TUBE
K971906 · Boston Scientific Corp · Aug 1997
STERILE FEEDING TUBE
K954218 · Baxter Healthcare Corp · Nov 1995
FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE
K912972 · Abbott Laboratories · Sep 1991