BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON— 510(k) K022521

Substantially Equivalent

Rockwell Medical Technologies, Inc.

FDA 510(k) clearance K022521 for BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON, Substantially Equivalent on 2003-01-03. Applicant: Rockwell Medical Technologies, Inc..

Clearance details

Applicant: Rockwell Medical Technologies, Inc.
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 2002-07-30
Decision date: 2003-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wixom, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.