Cleared Special

ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 (K060381) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K060381 · Renal Solutions, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
99d
Days
Class 2
Risk

K060381 is an FDA 510(k) clearance for the ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100. 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 May 24, 2006 after a review of 99 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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

Submission Details

510(k) Number K060381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2006
Decision Date May 24, 2006
Days to Decision 99 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
31d faster than avg
Panel avg: 130d · This submission: 99d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.