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

Name: FDA 510(k) clearance K954527
Creator: U.S. Food and Drug Administration
Published: 1996-03-01

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. Device class: 2.

Clearance details

Applicant: Rockwell Medical Supply
Product code: Code KPO
Device class: Class 2
Regulation: 21 CFR 876.5820
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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K243786 — Bicarby Dialysate RFP-402 (RFP-402-G) +7 more2025-04-04
K240920 — HemoCare Bicarbonate Concentrate Set (BCS)2024-07-12

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.