Cleared Special

K042224 - RM3 RENAL PRESERVATION SYSTEM

K042224 is an FDA 510(k) clearance for RM3 RENAL PRESERVATION SYSTEM, manufactured by Waters Instruments, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDN cleared through the Special 510(k) pathway after a 66-day FDA review.

K042224 · Waters Instruments, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
66d
Days
Class 2
Risk

K042224 is an FDA 510(k) clearance for the RM3 RENAL PRESERVATION SYSTEM. Classified as System, Perfusion, Kidney (product code KDN), Class II - Special Controls.

Submitted by Waters Instruments, Inc. (Plymouth, US). The FDA issued a Cleared decision on October 22, 2004 after a review of 66 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K042224

510(k) Number K042224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2004
Decision Date October 22, 2004
Days to Decision 66 days
Submission Type Special
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
65d faster than avg
Panel avg: 131d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

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 41
Devices cleared under the same product code (KDN) and FDA review panel - the closest regulatory comparables to K042224.
COSTORSOL
K083453 · Preservation Solutions, Inc. · Jan 2009
MAPERSOL
K080432 · Preservation Solutions, Inc. · Aug 2008
COSTORSOL
K073693 · Preservation Solutions, Inc. · Jul 2008
LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)
K021362 · Organ Recovery Systems, Inc. · Jul 2003
MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION
K022391 · Organ Recovery Systems, Inc. · Oct 2002
KPS-I, THE KIDNEY PERFUSION SOLUTION
K013575 · Organ Recovery Systems, Inc. · Jan 2002
K042224 · RM3 RENAL PRESERVATION SYSTEM
Download PDF FDA Summary Waters Instruments, I…