Cleared Traditional

K030784 - NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL

K030784 is an FDA 510(k) clearance for NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC..., manufactured by Applied Medical Technology, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 386-day FDA review.

K030784 · Applied Medical Technology, Inc. · Gastroenterology & Urology device
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Apr 2004
Decision
386d
Days
Class 2
Risk

K030784 is an FDA 510(k) clearance for the NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL. 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 April 1, 2004 after a review of 386 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K030784

510(k) Number K030784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2003
Decision Date April 01, 2004
Days to Decision 386 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
255d slower than avg
Panel avg: 131d · This submission: 386d
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 644
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K030784.
SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL)
K041034 · Entracare, LLC · Aug 2004
Y2K2 ENTERNAL FEEDING MANAGER
K030413 · Moss Medical Products · May 2004
CONVATEC FECAL MANAGEMENT SYSTEM
K032734 · Convatec, A Bristol-Myers Squibb Co. · Apr 2004
MOSSMED DUAL INTERMITTENT ASPIRATOR
K031492 · Moss Medical Products · Feb 2004
FASTRAC GASTRIC ACCESS PORT KIT
K033562 · C.R. Bard, Inc. · Dec 2003
COOK GASTRIC SIZING BALLOON CATHETER
K030841 · Cook, Inc. · Jul 2003
K030784 · NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL
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