Cleared Traditional

K192408 - Custodiol HTK Solution

K192408 is an FDA 510(k) clearance for Custodiol HTK Solution, manufactured by Dr. Franz Kohler Chemie GmbH. The device is a Class 2 Gastroenterology & Urology device with product code KDL cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K192408 · Dr. Franz Kohler Chemie GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Apr 2020
Decision
233d
Days
Class 2
Risk

K192408 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 (Bensheim, DE). The FDA issued a Cleared decision on April 24, 2020 after a review of 233 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

FDA 510(k) Submission Details - K192408

510(k) Number K192408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2019
Decision Date April 24, 2020
Days to Decision 233 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 131d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDL Device Classification - Class 2, Special Controls

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 15
Devices cleared under the same product code (KDL) and FDA review panel - the closest regulatory comparables to K192408.
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Servator M SALF Solution
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Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags
K170150 · S.A.L.F. Spa · Oct 2017
PERF-GEN PULSATILE PERFUSION SOLUTION
K121736 · Waters Medical Systems, LLC · Aug 2013
BEL-GEN COLD STORAGE SOLUTION
K121618 · Waters Medical Systems, LLC · Jun 2013