ACCUSOL DIALYSIS SOLUTION— 510(k) K041428

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K041428 for ACCUSOL DIALYSIS SOLUTION, Substantially Equivalent on 2004-08-27. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 2004-05-28
Decision date: 2004-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, 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.