Cleared Traditional

K022112 - FORTUNE ALL SILICONE STOMACH (GASTRIC) ...

K022112 is an FDA 510(k) clearance for FORTUNE ALL SILICONE STOMACH (GASTRIC) ..., manufactured by Fortune Medical Instrument Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K022112 · Fortune Medical Instrument Corp. · Gastroenterology & Urology device
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Apr 2003
Decision
279d
Days
Class 2
Risk

K022112 is an FDA 510(k) clearance for the FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Fortune Medical Instrument Corp. (Taipei Hsien, TW). The FDA issued a Cleared decision on April 3, 2003 after a review of 279 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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.

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FDA 510(k) Submission Details - K022112

510(k) Number K022112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2002
Decision Date April 03, 2003
Days to Decision 279 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
149d slower than avg
Panel avg: 130d · This submission: 279d
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 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K022112.
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