DeviceClearance

Bicarby Dialysate RFP-402 (RFP-402-G) +7 more— 510(k) K243786

Substantially Equivalent

Fresenius Medical Care Renal Therapies Group, LLC

FDA 510(k) clearance K243786 for Bicarby Dialysate RFP-402 (RFP-402-G) +7 more, Substantially Equivalent on 2025-04-04. Applicant: Fresenius Medical Care Renal Therapies Group, LLC. Device class: 2.

Clearance details

Device name as filed
Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
Product code
Code KPO
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Waltham, MA, US
Download summary PDFView on FDA.gov ↗

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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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K243786

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K243786.

Data sourced from openFDA. This site is unofficial and independent of the FDA.