NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)— 510(k) K253462

Substantially Equivalent

Fresenius Medical Care Renal Therapies Group, LLC

FDA 510(k) clearance K253462 for NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2), Substantially Equivalent on 2026-01-29. Applicant: Fresenius Medical Care Renal Therapies Group, LLC.

Clearance details

Applicant: Fresenius Medical Care Renal Therapies Group, LLC
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 2025-10-07
Decision date: 2026-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, 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.