Cleared Special

K112427 - BICARB MIXING AND DISTRIBUTION SYSTEM

K112427 is an FDA 510(k) clearance for BICARB MIXING AND DISTRIBUTION SYSTEM, manufactured by Isopure, Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FIN cleared through the Special 510(k) pathway after a 156-day FDA review.

K112427 · Isopure, Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K112427

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 131d · This submission: 156d
Pathway characteristics
Modification to existing cleared device.

FIN Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FIN Tank, Holding, Dialysis

All 17
Devices cleared under the same product code (FIN) and FDA review panel - the closest regulatory comparables to K112427.
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DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM
K060333 · Dialysis Services, Inc. · Sep 2006
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K051031 · Ameriwater · Jan 2006
USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM
K031502 · Usfilter · Aug 2004
K112427 · BICARB MIXING AND DISTRIBUTION SYSTEM
Download PDF FDA Summary Isopure, Corp.