Cleared Traditional

CUSTODIOL HTK SOLUTION (K020924) - FDA 510(k) Clearance

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

K020924 · Dr. Franz Kohler Chemie GmbH · Gastroenterology & Urology device
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Jan 2003
Decision
291d
Days
Class 2
Risk

K020924 is an FDA 510(k) clearance for the CUSTODIOL HTK SOLUTION. Classified as Set, Perfusion, Kidney, Disposable (product code KDL), Class II - Special Controls.

Submitted by Dr. Franz Kohler Chemie GmbH (Brookeville, US). The FDA issued a Cleared decision on January 6, 2003 after a review of 291 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 K020924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2002
Decision Date January 06, 2003
Days to Decision 291 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
161d slower than avg
Panel avg: 130d · This submission: 291d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDL Set, Perfusion, Kidney, Disposable
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 - KDL Set, Perfusion, Kidney, Disposable

All 18
Devices cleared under the same product code (KDL) and FDA review panel - the closest regulatory comparables to K020924.
OrganProtex HTK Solution
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PERF-GEN Pulsatile Perfusion Solution
K221386 · Institut Georges Lopez · Jun 2022
BEL-GEN Cold Storage Solution
K221387 · Institut Georges Lopez · Jun 2022
Servator M SALF Solution
K211842 · S.A.L.F. Spa · Dec 2021
Custodiol HTK Solution
K192408 · Dr. Franz Kohler Chemie GmbH · Apr 2020