MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X— 510(k) K131202

Substantially Equivalent

Dialysis Medical Solutions, LLC

FDA 510(k) clearance K131202 for MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X, Substantially Equivalent on 2014-04-03. Applicant: Dialysis Medical Solutions, LLC.

Clearance details

Applicant: Dialysis Medical Solutions, LLC
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 2013-04-29
Decision date: 2014-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbus, OH, 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.