Cleared Traditional

K020924 - CUSTODIOL HTK SOLUTION

K020924 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 291-day FDA review.

K020924 · Dr. Franz Kohler Chemie GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K020924

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
160d slower than avg
Panel avg: 131d · This submission: 291d
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 16
Devices cleared under the same product code (KDL) and FDA review panel - the closest regulatory comparables to K020924.
BEL-GEN COLD STORAGE SOLUTION
K121618 · Waters Medical Systems, LLC · Jun 2013
SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L
K091656 · Organ Recovery Systems, Inc. · Mar 2010
CUSTODIOL
K043461 · Dr. Franz Kohler Chemie GmbH · Feb 2005
GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET
K955497 · Cobe Renal Care, Inc. · Sep 1997
VIASPAN (BELZER UW - CSS)
K944866 · The Dupont Merck Pharmaceutical Co. · Apr 1996
MOP CATHETER
K891239 · Bivona Medical Technologies · Nov 1989