Cleared Traditional

K971434 - A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE

K971434 is an FDA 510(k) clearance for A.M.T. G-TUBE BALLOON REPLACEMENT GASTR..., manufactured by Applied Medical Technologies. The device is a Class 2 Gastroenterology & Urology device with 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

FDA 510(k) Submission Details - K971434

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
355d slower than avg
Panel avg: 131d · This submission: 486d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

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 489
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K971434.
TRIP TONOMETRY CATHETER, 16F
K983366 · Datex-Engstrom, Inc. · Dec 1998
COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE
K981323 · Novartis Nutrition Corp. · Oct 1998
MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT
K982894 · Ballard Medical Products · Sep 1998
RUSCH BLAKEMORE 3 LUMEN, STERILE
K981203 · Rusch Intl. · Jun 1998
RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE)
K973892 · Rusch Intl. · May 1998
AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE
K980305 · Applied Medical Technology, Inc. · Apr 1998