Cleared Traditional

K980145 - AMT DECOMPRESSION TUBES

K980145 is the FDA 510(k) clearance for AMT DECOMPRESSION TUBES by Applied Medical Technology, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KGC) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K980145 · Applied Medical Technology, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
85d
Days
Class 2
Risk

K980145 is an FDA 510(k) clearance for the AMT DECOMPRESSION TUBES. Classified as Tube, Gastro-enterostomy (product code KGC), Class II - Special Controls.

Submitted by Applied Medical Technology, Inc. (Cleveland, US). The FDA issued a Cleared decision on April 10, 1998 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Applied Medical Technology, Inc. devices

Submission Details

510(k) Number K980145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1998
Decision Date April 10, 1998
Days to Decision 85 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
45d faster than avg
Panel avg: 130d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KGC Tube, Gastro-enterostomy
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 - KGC Tube, Gastro-enterostomy

All 12
Devices cleared under the same product code (KGC) and FDA review panel - the closest regulatory comparables to K980145.
KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM
K093312 · Kimberly-Clark Corp. · Dec 2009
MEDLINE GASTROSTOMY TUBE
K073718 · Medline Industries, Inc. · Mar 2008
KIMBERLY-CLARK INTRODUCER KITS
K080253 · Kimberly-Clark Corp. · Feb 2008
BARD REPLACEMENT GASTROSTOMY TUBE
K910492 · C.R. Bard, Inc. · Jul 1991
BUTTON REPLACEMENT GASTROSTOMY DEVICE
K904779 · C.R. Bard, Inc. · Jan 1991