HemoCare Bicarbonate Concentrate Set (BCS)— 510(k) K240920

Substantially Equivalent

Deka Research and Development

FDA 510(k) clearance K240920 for HemoCare Bicarbonate Concentrate Set (BCS), Substantially Equivalent on 2024-07-12. Applicant: Deka Research and Development.

Clearance details

Applicant: Deka Research and Development
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 2024-04-04
Decision date: 2024-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchester, NH, 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.