Cleared Traditional

K042300 - AMT INTRODUCER: MINI BUTTON DELIVERY SY...

K042300 is the FDA 510(k) clearance for AMT INTRODUCER: MINI BUTTON DELIVERY SY... by Applied Medical Technology, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K042300 · Applied Medical Technology, Inc. · Gastroenterology & Urology device
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Oct 2004
Decision
62d
Days
Class 2
Risk

K042300 is an FDA 510(k) clearance for the AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Applied Medical Technology, Inc. (Cleveland, US). The FDA issued a Cleared decision on October 25, 2004 after a review of 62 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 K042300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2004
Decision Date October 25, 2004
Days to Decision 62 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
68d faster than avg
Panel avg: 130d · This submission: 62d
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 253
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K042300.
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FASTRAC GASTRIC ACCESS PORT KIT
K033562 · C.R. Bard, Inc. · Dec 2003
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K031538 · Boston Scientific Corp · Jun 2003