KDJ · Class II · 21 CFR 876.5630

FDA Product Code KDJ: Set, Administration, For Peritoneal Dialysis, Disposable

Leading manufacturers include Baxter Healthcare Corp, Abbott Laboratories and Fresenius Medical Care Renal Therapies Group, LLC.

113
Total
113
Cleared
107d
Avg days
1977
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 50d recently vs 108d historically

FDA 510(k) Cleared Set, Administration, For Peritoneal Dialysis, Disposable Devices (Product Code KDJ)

113 devices
1–24 of 113
Cleared Apr 03, 2025
stay•safe® catheter extension set with Safe- Lock, 12 inch
K250404
Fresenius Medical Care Renal Therapies Group, LLC
Gastroenterology & Urology · 50d
Cleared Mar 12, 2024
MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A
K231849
Baxter Healthcare
Gastroenterology & Urology · 263d
Cleared Mar 18, 2022
15L Cycler Drainage Bag
K214016
Baxter Healthcare Corporation
Gastroenterology & Urology · 86d
Cleared Oct 25, 2019
MiniCap Extended Life PD Transfer Sets
K192705
Baxter Healthcare
Gastroenterology & Urology · 28d
Cleared May 21, 2018
stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch
K173593
Fresenius Medical Care Renal Therapies Group, LLC
Gastroenterology & Urology · 181d
Cleared Feb 14, 2018
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
K173651
Fresenius Medical Care Renal Therapies Group, LLC
Gastroenterology & Urology · 78d
Cleared Jan 24, 2018
Cycler Drain Bag Set
K173363
Fresenius Medical Care Renal Therapies Group, LLC
Gastroenterology & Urology · 90d
Cleared Nov 20, 2003
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
K031676
Baxter Healthcare Corp
Gastroenterology & Urology · 174d
Cleared Oct 01, 1997
HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE
K972579
Baxter Healthcare Corp
Gastroenterology & Urology · 83d
Cleared Aug 06, 1996
ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493
K961825
Baxter Healthcare Corp
Gastroenterology & Urology · 88d
Cleared Mar 28, 1994
ABBOTT SMART CAP
K921818
Abbott Laboratories
Gastroenterology & Urology · 712d
Cleared Feb 22, 1994
BAXTER APD 12' EXTENSION LINE
K925403
Baxter Healthcare Corp
Gastroenterology & Urology · 487d
Cleared Feb 19, 1992
ABBOTT SMART CAP
K915304
Abbott Laboratories
Gastroenterology & Urology · 90d
Cleared Nov 20, 1990
CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481
K902526
Baxter Healthcare Corp
Gastroenterology & Urology · 168d
Cleared Jan 29, 1990
DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466
K895631
Baxter Healthcare Corp
Gastroenterology & Urology · 132d
Cleared Jan 29, 1990
CONNECTION SHIELDS CODES 5C4213 AND 5C4215
K895673
Baxter Healthcare Corp
Gastroenterology & Urology · 131d
Cleared Sep 07, 1989
PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP
K894783
Baxter Healthcare Corp
Gastroenterology & Urology · 42d
Cleared Oct 21, 1988
CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS
K883239
Baxter Healthcare Corp
Gastroenterology & Urology · 81d
Cleared Jul 13, 1988
EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC4373
K882455
Baxter Healthcare Corp
Gastroenterology & Urology · 29d
Cleared Jul 13, 1988
EXTENDED LIFE CAPD TRANSFER SET 5C4444
K882498
Baxter Healthcare Corp
Gastroenterology & Urology · 26d
Cleared Apr 10, 1987
CAPD Y-ADMIN. SET USED W/INPERSOL BIOCAP ADMIN.
K871049
Abbott Laboratories
Gastroenterology & Urology · 24d
Cleared Apr 10, 1987
CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM.
K871050
Abbott Laboratories
Gastroenterology & Urology · 24d
Cleared Jan 29, 1981
INPERSOL CAPD BAG PORT CLAMP
K803300
Abbott Laboratories
Gastroenterology & Urology · 30d
Cleared Oct 10, 1980
INPERSOL-CAPD ADMINISTRATION SET
K801881
Abbott Laboratories
Gastroenterology & Urology · 64d

About Product Code KDJ - Regulatory Context

510(k) Submission Activity

113 total 510(k) submissions under product code KDJ since 1977, with 113 receiving FDA clearance (average review time: 107 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - KDJ Product Code

Recent submissions under KDJ have taken an average of 50 days to reach a decision - down from 108 days historically, suggesting improved FDA processing for this classification.

KDJ devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →