Cleared Traditional

HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER (K012328) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 29
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K012328.
ACCUSOL DIALYSIS SOLUTION
K041428 · Baxter Healthcare Corp · Aug 2004
B. BRAUN BICARBONATE DIALYSATE
K041683 · B.Braun Medical, Inc. · Aug 2004
B.BRAUN PREMIXED DIALYSATE
K034066 · B.Braun Medical, Inc. · Mar 2004
PREMIXED DIALYSATE FOR HEMODIAFILTRATION
K910270 · Baxter Healthcare Corp · Apr 1991
BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE
K895199 · Baxter Healthcare Corp · Dec 1989
BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS
K884725 · Baxter Healthcare Corp · Jan 1989