Cleared Traditional

ENDOLUMINAL ACCESS TUBE (K941228) - FDA 510(k) Clearance

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

K941228 · Med Institute, Inc. · Gastroenterology & Urology device
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Sep 1995
Decision
561d
Days
Class 2
Risk

K941228 is an FDA 510(k) clearance for the ENDOLUMINAL ACCESS TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Med Institute, Inc. (West Lafayette, US). The FDA issued a Cleared decision on September 27, 1995 after a review of 561 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 Med Institute, Inc. devices

Submission Details

510(k) Number K941228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 15, 1994
Decision Date September 27, 1995
Days to Decision 561 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
431d slower than avg
Panel avg: 130d · This submission: 561d
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 125
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K941228.
KANGAROO FEEDING TUBE PLACMENT STYLET
K960632 · Sherwood Medical Co. · May 1996
KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT
K954429 · Sherwood Medical Co. · Mar 1996
BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES
K946249 · C.R. Bard, Inc. · Dec 1995
FLEXIFLO SIX ENTERAL NUTRITION PUMP SET
K943240 · Abbott Laboratories · Apr 1995
FLEXIFLO NASOENTERIC FEEDING TUBE
K922217 · Abbott Laboratories · Mar 1995
FLEXIFLO TUBE PLACEMENT VERIFIER
K922216 · Abbott Laboratories · Jan 1995