Cleared Traditional

K973253 - ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE

K973253 is an FDA 510(k) clearance for ROCKWELL MEDICAL SUPPLY, manufactured by International Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K973253 · International Medical Products, Inc. · Gastroenterology & Urology device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K973253

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
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

69d faster than avg

Panel avg: 131d · This submission: 62d

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 108

Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K973253.

ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES

K981003 · International Medical Products, Inc. · Jun 1998

DRYALYSATE CONCENTRATE

K980659 · Advanced Renal Technologies, Inc. · Jun 1998

DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL

K981043 · Solution Technologies · May 1998

ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS

K971053 · International Medical Products, Inc. · Jun 1997

ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS

K954527 · Rockwell Medical Supply · Mar 1996

FRESENIUS DIALYSATE ACID CONCENTRATE

K922088 · Fresenius USA, Inc. · Oct 1994

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K973253

International Medical Products, Inc.

Minneapolis, MN · US

JEFFREY R SHIDEMAN

Regulatory profile

9 submissions 9 cleared

100% clearance rate · Active in Gastroenterology & Urology

View all devices by International Medical Products, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: October 30, 1997. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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