Cleared Traditional

K992209 - CUSTODIOL

K992209 is an FDA 510(k) clearance for CUSTODIOL, manufactured by Dr. Franz Kohler Chemie GmbH. The device is a Class 2 Gastroenterology & Urology device with product code KDN cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K992209 · Dr. Franz Kohler Chemie GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
163d
Days
Class 2
Risk

K992209 is an FDA 510(k) clearance for the CUSTODIOL. Classified as System, Perfusion, Kidney (product code KDN), Class II - Special Controls.

Submitted by Dr. Franz Kohler Chemie GmbH (Rockville, US). The FDA issued a Cleared decision on December 10, 1999 after a review of 163 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 - K992209

510(k) Number K992209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1999
Decision Date December 10, 1999
Days to Decision 163 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
32d slower than avg
Panel avg: 131d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDN Device Classification - Class 2, Special Controls

Product Code KDN System, Perfusion, Kidney
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 - KDN System, Perfusion, Kidney

All 37
Devices cleared under the same product code (KDN) and FDA review panel - the closest regulatory comparables to K992209.
MAPERSOL
K080432 · Preservation Solutions, Inc. · Aug 2008
COSTORSOL
K073693 · Preservation Solutions, Inc. · Jul 2008
RM3 RENAL PRESERVATION SYSTEM
K042224 · Waters Instruments, Inc. · Oct 2004
HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1
K990229 · Justec Medical Products, Inc. · Nov 1999
BELZER-MPS
K972066 · Trans-Med Corp. · Nov 1997
RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT
K971571 · Waters Instruments, Inc. · Jul 1997