Cleared Traditional

ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE (K973253) - FDA 510(k) Clearance

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

K973253 · International Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
62d
Days
Class 2
Risk

K973253 is an FDA 510(k) clearance for the ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by International Medical Products, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 30, 1997 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all International Medical Products, Inc. devices

Submission Details

510(k) Number K973253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1997
Decision Date October 30, 1997
Days to Decision 62 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 130d · This submission: 62d
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 30
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K973253.
ACCUSOL DIALYSIS SOLUTION
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B. BRAUN BICARBONATE DIALYSATE
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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