FKPClass II

System, Dialysate Delivery, Single Patient

21 CFR 876.5820 / Gastroenterology, Urology

FKP is the FDA product code for System, Dialysate Delivery, Single Patient, a class II device type, regulated under 21 CFR 876.5820. As of 2026-09-10, FDA records hold 50 510(k) clearances under this code, the most recent dated 2018-09-26, and 12 recalls.

Classification record

Product code: FKP
Device name: System, Dialysate Delivery, Single Patient
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: 50
Ingested recalls: 12

Clearances, product code FKP

By decision year

50 clearances under product code FKP with a decision year between 1977 and 2018, 1985 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code FKP by decision year
Year	Clearances
1977	4
1978	2
1979	2
1980	4
1981	2
1982	1
1985	6
1986	3
1987	3
1988	1
1989	3
1990	2
1991	4
1994	1
1995	2
1996	2
1997	1
1999	1
2001	1
2002	1
2004	1
2013	2
2018	1

Applicants with the most clearances

Product code FKP

Applicants holding the most 510(k) clearances under product code FKP
Applicant	Clearances
Gambro, Inc.	6
Cobe Laboratories, Inc.	4
Extracorporeal Medical Specialities, Inc.	4
Fresenius USA, Inc.	4
NxStage Medical Inc	4
Baxter Healthcare Corporation	3
BD Becton Dickinson Vacutainer Systems Preanalytic	3
Cd Medical, Inc.	3
Hospal Medical Corp.	3
Integrated Biomedical Technology, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code