Cleared Traditional

K012328 - HEMO-LYTE HEMODIALYSIS GRADE SODIUM BIC...

K012328 is an FDA 510(k) clearance for HEMO-LYTE HEMODIALYSIS GRADE SODIUM BIC..., manufactured by Di-Chem, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K012328 · Di-Chem, Inc. · Gastroenterology & Urology device
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Jan 2002
Decision
179d
Days
Class 2
Risk

K012328 is an FDA 510(k) clearance for the HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Di-Chem, Inc. (Champlin, US). The FDA issued a Cleared decision on January 18, 2002 after a review of 179 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. 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 Di-Chem, Inc. devices

FDA 510(k) Submission Details - K012328

510(k) Number K012328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2001
Decision Date January 18, 2002
Days to Decision 179 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 130d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPO Device Classification - Class 2, Special Controls

Product Code KPO Dialysate Concentrate For Hemodialysis (liquid Or Powder)
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 - KPO Dialysate Concentrate For Hemodialysis (liquid Or Powder)

All 59
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K012328.
NXSTAGE PUREFLOW SOLUTION
K033386 · Nxstage Medical, Inc. · Nov 2003
NXSTAGE PREMIXED DIALYSATE
K022913 · Nxstage Medical, Inc. · Oct 2002
NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100
K013655 · Nxstage Medical, Inc. · Feb 2002
PRISMASATE
K013448 · Gambro Renal Products · Jan 2002
BICART
K013724 · Gambro Renal Products · Jan 2002
DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
K011368 · Gambro Renal Products · Aug 2001