B. BRAUN MODIFIED BICARBONATE DIALYSATE— 510(k) K052393

Substantially Equivalent

B.Braun Medical, Inc.

FDA 510(k) clearance K052393 for B. BRAUN MODIFIED BICARBONATE DIALYSATE, Substantially Equivalent on 2005-11-09. Applicant: B.Braun Medical, Inc..

Clearance details

Applicant: B.Braun Medical, Inc.
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 2005-08-31
Decision date: 2005-11-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Allentown, PA, 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.