KDJClass II

Set, Administration, For Peritoneal Dialysis, Disposable

21 CFR 876.5630 / Gastroenterology, Urology

KDJ is the FDA product code for Set, Administration, For Peritoneal Dialysis, Disposable, a class II device type, regulated under 21 CFR 876.5630. As of 2026-09-10, FDA records hold 113 510(k) clearances under this code, the most recent dated 2025-04-03, and 61 recalls.

Classification record

Product code: KDJ
Device name: Set, Administration, For Peritoneal Dialysis, Disposable
Regulation: 21 CFR 876.5630
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: 113
Ingested recalls: 61

Clearances, product code KDJ

By decision year

113 clearances under product code KDJ with a decision year between 1977 and 2025, 1990 the highest year at 29.

Show the numbers

510(k) clearances under FDA product code KDJ by decision year
Year	Clearances
1977	1
1978	4
1979	4
1980	6
1981	11
1982	2
1985	4
1986	2
1987	8
1988	4
1989	6
1990	29
1991	2
1992	4
1993	1
1994	3
1995	1
1996	1
1997	3
1999	1
2003	2
2004	2
2008	1
2013	1
2015	2
2016	1
2018	3
2019	1
2022	1
2024	1
2025	1

Applicants with the most clearances

Product code KDJ

Applicants holding the most 510(k) clearances under product code KDJ
Applicant	Clearances
National Medical Care, Medical Products Div., Inc.	30
Baxter Healthcare Corporation	16
Travenol Laboratories, S.A.	12
Abbott Medical	7
American Medical Products LLC	7
Fresenius Medical Care Renal Therapies Group, LLC	7
Delmed, Inc.	6
Dravon Medical, Inc.	3
Fresenius USA, Inc.	3
Medionics International, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order