Cleared Traditional

CUSTODIOL (K032794) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032794 · Dr. Franz Kohler Chemie GmbH · Gastroenterology & Urology device
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Apr 2004
Decision
210d
Days
Class 2
Risk

K032794 is an FDA 510(k) clearance for the CUSTODIOL. Classified as System And Accessories, Isolated Heart, Transport And Preservation (product code MSB), Class II - Special Controls.

Submitted by Dr. Franz Kohler Chemie GmbH (Brookeville, US). The FDA issued a Cleared decision on April 5, 2004 after a review of 210 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5880 - 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.

View all Dr. Franz Kohler Chemie GmbH devices

Submission Details

510(k) Number K032794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2003
Decision Date April 05, 2004
Days to Decision 210 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
80d slower than avg
Panel avg: 130d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSB System And Accessories, Isolated Heart, Transport And Preservation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5880
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 - MSB System And Accessories, Isolated Heart, Transport And Preservation

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