Cleared Special

BICARB MIXING AND DISTRIBUTION SYSTEM (K112427) - FDA 510(k) Clearance

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

K112427 · Isopure, Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
156d
Days
Class 2
Risk

K112427 is an FDA 510(k) clearance for the BICARB MIXING AND DISTRIBUTION SYSTEM. Classified as Tank, Holding, Dialysis (product code FIN), Class II - Special Controls.

Submitted by Isopure, Corp. (Simpsonville, US). The FDA issued a Cleared decision on January 26, 2012 after a review of 156 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Isopure, Corp. devices

Submission Details

510(k) Number K112427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2011
Decision Date January 26, 2012
Days to Decision 156 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
26d slower than avg
Panel avg: 130d · This submission: 156d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FIN Tank, Holding, Dialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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.