Cleared Traditional

ENFUSE ENTERAL FEEDING TUBE (K922998) - FDA 510(k) Clearance

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

K922998 · Rusch, Inc. · Gastroenterology & Urology device
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Dec 1993
Decision
529d
Days
Class 2
Risk

K922998 is an FDA 510(k) clearance for the ENFUSE ENTERAL FEEDING TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Rusch, Inc. (Jeffrey, US). The FDA issued a Cleared decision on December 3, 1993 after a review of 529 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Rusch, Inc. devices

Submission Details

510(k) Number K922998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1992
Decision Date December 03, 1993
Days to Decision 529 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
399d slower than avg
Panel avg: 130d · This submission: 529d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNT Tubes, Gastrointestinal (and Accessories)
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 143
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K922998.
FLEXIFLO GASTROSTOMY KIT
K932861 · Abbott Laboratories · Jun 1994
WILSON-COOK BALLOON INFLATION DEVICE
K936168 · Wilson-Cook Medical, Inc. · Mar 1994
GASTROINTESTINAL FEEDING TUBE
K920703 · Wilson-Cook Medical, Inc. · Dec 1993
FLEXIFLO 60 NASOJEJUNAL FEEDING TUBE
K924996 · Abbott Laboratories · Oct 1993
FLEXIFLO LAPAROSCOPIC GASTROSTOMY KIT
K924697 · Abbott Laboratories · Aug 1993
BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC
K915841 · C.R. Bard, Inc. · Jun 1993