Cleared Traditional

CUSTODIOL (K043461) - FDA 510(k) Clearance

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

K043461 · Dr. Franz Kohler Chemie GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
75d
Days
Class 2
Risk

K043461 is an FDA 510(k) clearance for the CUSTODIOL. 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 February 28, 2005 after a review of 75 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dr. Franz Kohler Chemie GmbH devices

Submission Details

510(k) Number K043461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2004
Decision Date February 28, 2005
Days to Decision 75 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
55d faster than avg
Panel avg: 130d · This submission: 75d
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
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