ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS— 510(k) K954527

Substantially Equivalent

Rockwell Medical Supply

FDA 510(k) clearance K954527 for ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS, Substantially Equivalent on 1996-03-01. Applicant: Rockwell Medical Supply.

Clearance details

Applicant: Rockwell Medical Supply
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 1995-09-29
Decision date: 1996-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wixom, MI, US

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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.