KDIClass II

Dialyzer, High Permeability With Or Without Sealed Dialysate System

21 CFR 876.5860 / Gastroenterology, Urology

KDI is the FDA product code for Dialyzer, High Permeability With Or Without Sealed Dialysate System, a class II device type, regulated under 21 CFR 876.5860. As of 2026-09-10, FDA records hold 345 510(k) clearances under this code, the most recent dated 2026-07-24, and 217 recalls.

Classification record

Product code: KDI
Device name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation: 21 CFR 876.5860
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: 345
Ingested recalls: 217

Clearances, product code KDI

By decision year

345 clearances under product code KDI with a decision year between 1978 and 2026, 1995 the highest year at 19.

Show the numbers

510(k) clearances under FDA product code KDI by decision year
Year	Clearances
1978	2
1979	1
1980	5
1981	3
1982	4
1983	10
1984	9
1985	11
1986	7
1987	6
1988	5
1989	5
1990	6
1991	4
1992	2
1993	1
1994	7
1995	19
1996	5
1997	13
1998	10
1999	10
2000	11
2001	12
2002	12
2003	12
2004	8
2005	7
2006	8
2007	11
2008	6
2009	4
2010	9
2011	5
2012	6
2013	11
2014	8
2015	5
2016	5
2017	8
2018	2
2019	4
2020	9
2021	2
2022	7
2023	7
2024	7
2025	9
2026	5

Applicants with the most clearances

Product code KDI

Applicants holding the most 510(k) clearances under product code KDI
Applicant	Clearances
Fresenius Medical Care Renal Therapies Group, LLC	36
Baxter Healthcare Corporation	27
NxStage Medical Inc	26
Hospal Medical Corp.	20
Althin Medical AB an Affiliate of Baxter Intl	18
Gambro Renal Products	18
Gambro, Inc.	15
Chf Solutions, Inc.	11
Medivators Inc	11
Outset Medical, Inc.	9

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 75 companies shown, in name order