FIKClass II

System, Dialysate Delivery, Recirculating

21 CFR 876.5820 / Gastroenterology, Urology

FIK is the FDA product code for System, Dialysate Delivery, Recirculating, a class II device type, regulated under 21 CFR 876.5820. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: FIK
Device name: System, Dialysate Delivery, Recirculating
Regulation: 21 CFR 876.5820
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code FIK.

Recent clearances

Product code FIK

FDA records hold no clearances under product code FIK.

Recent recalls

Product code FIK

Z-1245-2015Class IIAdditional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperitoneal Volume (IIPV)...Baxter Healthcare Corp. / initiated 2014-04-03 / 55 systems

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)