Cleared Traditional

ANTI-I.V. ENTERAL FEEDING SYSTEM (K043044) - FDA 510(k) Clearance

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

K043044 · Viasys Medsystems · Gastroenterology & Urology device
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May 2005
Decision
183d
Days
Class 2
Risk

K043044 is an FDA 510(k) clearance for the ANTI-I.V. ENTERAL FEEDING SYSTEM. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Viasys Medsystems (Wheeling, US). The FDA issued a Cleared decision on May 6, 2005 after a review of 183 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 Viasys Medsystems devices

Submission Details

510(k) Number K043044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2004
Decision Date May 06, 2005
Days to Decision 183 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
53d slower than avg
Panel avg: 130d · This submission: 183d
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 165
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K043044.
ENTAKE STANDARD AND SAFETY PEG SYSTEM
K061021 · Conmedcorp · Apr 2006
SMALL INTESTINAL VIDEOSCOPE SYSTEM
K051551 · Olympus Medical Systems Corporation · Jun 2005
WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE
K043203 · Wilson-Cook Medical, Inc. · May 2005
KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE
K043114 · Kimberly-Clark Corp. · Dec 2004
FASTRAC GASTRIC ACCESS PORT KIT
K033562 · C.R. Bard, Inc. · Dec 2003
COOK GASTRIC SIZING BALLOON CATHETER
K030841 · Cook, Inc. · Jul 2003