Cleared Special

ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 (K070739) - FDA 510(k) Clearance

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

K070739 · Renal Solutions, Inc. · Gastroenterology & Urology device
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May 2007
Decision
70d
Days
Class 2
Risk

K070739 is an FDA 510(k) clearance for the ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500. 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 25, 2007 after a review of 70 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

Submission Details

510(k) Number K070739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2007
Decision Date May 25, 2007
Days to Decision 70 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 130d · This submission: 70d
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.