Cleared Traditional

K971434 - A.M.T. G-TUBE BALLOON REPLACEMENT GASTR...

K971434 is the FDA 510(k) clearance for A.M.T. G-TUBE BALLOON REPLACEMENT GASTR... by Applied Medical Technologies. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 486-day FDA review.

K971434 · Applied Medical Technologies · Gastroenterology & Urology device
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Aug 1998
Decision
486d
Days
Class 2
Risk

K971434 is an FDA 510(k) clearance for the A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Applied Medical Technologies (Cleveland, US). The FDA issued a Cleared decision on August 17, 1998 after a review of 486 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 Applied Medical Technologies devices

Submission Details

510(k) Number K971434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1997
Decision Date August 17, 1998
Days to Decision 486 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
356d slower than avg
Panel avg: 130d · This submission: 486d
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 291
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K971434.
BARD BALLOON INFLATION SYSTEM
K991375 · C.R. Bard, Inc. · Sep 1999
TRIP TONOMETRY CATHETER, 8F
K992181 · Datex-Ohmeda, Inc. · Aug 1999
CHAIT CECOSTOMY CATHETER
K982500 · Cook, Inc. · Jan 1999
RUSCH BLAKEMORE 3 LUMEN, STERILE
K981203 · Rusch Intl. · Jun 1998
RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE)
K973892 · Rusch Intl. · May 1998
VYGON NEO-SUMP
K974806 · Vygon Corp. · Mar 1998