FJIClass II

Dialyzer, Capillary, Hollow Fiber

21 CFR 876.5820 / Gastroenterology, Urology

FJI is the FDA product code for Dialyzer, Capillary, Hollow Fiber, a class II device type, regulated under 21 CFR 876.5820. As of 2026-09-10, FDA records hold 131 510(k) clearances under this code, the most recent dated 2019-08-23, and 7 recalls.

Classification record

Product code: FJI
Device name: Dialyzer, Capillary, Hollow Fiber
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: 131
Ingested recalls: 7

Clearances, product code FJI

By decision year

131 clearances under product code FJI with a decision year between 1976 and 2019, 1980 the highest year at 21.

Show the numbers

510(k) clearances under FDA product code FJI by decision year
Year	Clearances
1976	1
1977	4
1978	4
1979	7
1980	21
1981	4
1982	5
1985	7
1986	6
1987	6
1988	14
1989	8
1990	4
1991	1
1993	1
1994	1
1995	14
1996	5
1997	3
1998	4
1999	4
2000	2
2001	2
2005	1
2013	1
2019	1

Applicants with the most clearances

Product code FJI

Applicants holding the most 510(k) clearances under product code FJI
Applicant	Clearances
Gambro, Inc.	10
Baxter Healthcare Corporation	9
National Medical Care, Medical Products Div., Inc.	9
Cordis US Corp.	8
bioMerieux, Inc.	7
Althin Medical AB an Affiliate of Baxter Intl	6
Cobe Laboratories, Inc.	6
Terumo Medical Corp.	6
Erika, Inc.	5
Terumo America, Inc.	5

Companies listing this code with FDA

Companies whose registered establishments list this code