Cleared Special

K123835 - 2008 HEMODIALYSIS SORBENT SYSTEM

K123835 is an FDA 510(k) clearance for 2008 HEMODIALYSIS SORBENT SYSTEM, manufactured by Renal Solutions, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKT cleared through the Special 510(k) pathway after a 64-day FDA review.

K123835 · Renal Solutions, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Feb 2013
Decision
64d
Days
Class 2
Risk

K123835 is an FDA 510(k) clearance for the 2008 HEMODIALYSIS SORBENT SYSTEM. Classified as System, Dialysate Delivery, Sorbent Regenerated (product code FKT), Class II - Special Controls.

Submitted by Renal Solutions, Inc. (Warrendale, US). The FDA issued a Cleared decision on February 15, 2013 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5600 - 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.

View all Renal Solutions, Inc. devices

FDA 510(k) Submission Details - K123835

510(k) Number K123835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2012
Decision Date February 15, 2013
Days to Decision 64 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 130d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

FKT Device Classification - Class 2, Special Controls

Product Code FKT System, Dialysate Delivery, Sorbent Regenerated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5600
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 - FKT System, Dialysate Delivery, Sorbent Regenerated

All 9
Devices cleared under the same product code (FKT) and FDA review panel - the closest regulatory comparables to K123835.
REDY 2000
K882428 · Organon Teknika Corp. · Oct 1988
PACKETS FOR PREP. OF DIALYSATES & INFUSATES -
K851188 · Organon Teknika Corp. · Apr 1985
HEMOPERFUSION PROCEDURE W/REDY 2000
K842513 · Organon Teknika Corp. · Sep 1984
SORB II
K813574 · Organon Teknika Corp. · Mar 1982
D-3260 SORBENT CARTRIDGE
K812869 · Organon Teknika Corp. · Dec 1981
D-3160 SORBENT CARTRIDGE
K811170 · Organon Teknika Corp. · Jul 1981