Cleared Traditional

K031099 - SORB+HISORB+CARTRIDGE

K031099 is an FDA 510(k) clearance for SORB+HISORB+CARTRIDGE, manufactured by Renal Solutions, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKT cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K031099 · Renal Solutions, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
163d
Days
Class 2
Risk

K031099 is an FDA 510(k) clearance for the SORB+HISORB+CARTRIDGE. Classified as System, Dialysate Delivery, Sorbent Regenerated (product code FKT), Class II - Special Controls.

Submitted by Renal Solutions, Inc. (Apollo, US). The FDA issued a Cleared decision on September 17, 2003 after a review of 163 days - an extended review cycle.

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

FDA 510(k) Submission Details - K031099

510(k) Number K031099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2003
Decision Date September 17, 2003
Days to Decision 163 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
32d slower than avg
Panel avg: 131d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 15
Devices cleared under the same product code (FKT) and FDA review panel - the closest regulatory comparables to K031099.
ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500
K070739 · Renal Solutions, Inc. · May 2007
ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100
K060381 · Renal Solutions, Inc. · May 2006
ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000
K043574 · Renal Solutions, Inc. · Jun 2005
REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)
K954623 · Gambro Healthcare · Aug 1996
REDY 2000
K882428 · Organon Teknika Corp. · Oct 1988
PACKETS FOR PREP. OF DIALYSATES & INFUSATES -
K851188 · Organon Teknika Corp. · Apr 1985