K252180
- 510(k) number
- K252180
- Device name
- Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC MA · US
- Product code
- KPO — Dialysate Concentrate For Hemodialysis (Liquid Or Po
- Decision date
- 2025-09-09
- Date received
- 2025-07-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K252180.pdf
Official FDA record: K252180
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.