KDJ · Class II · 21 CFR 876.5630

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

Leading manufacturers include National Medical Care, Medical Products Div., Inc., Travenol Laboratories, S.A. and Baxter Healthcare Corp.

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 Oct 29, 2015
FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution
K152129
Baxter Healthcare Corporation
Gastroenterology & Urology · 90d
Cleared Dec 29, 2008
FRESENIUS STERILE STAY SAFE CAP
K083542
Fresenius Medical Care North America
Gastroenterology & Urology · 31d
Cleared Sep 24, 2004
FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211
K041792
Fresenius Medical Care North America
Gastroenterology & Urology · 84d
Cleared Nov 20, 2003
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
K031676
Baxter Healthcare Corp
Gastroenterology & Urology · 174d
Cleared Mar 05, 2003
FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
K022412
Fresenius Medical Care North America
Gastroenterology & Urology · 224d
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 Aug 31, 1994
RAPID DISCONNECT Y-SET, CAT. NO. 48-7000
K930843
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 559d
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 25, 1993
FRESENIUS VARIABLE FILL MONITOR
K921052
Fresenius USA, Inc.
Gastroenterology & Urology · 357d
Cleared Sep 21, 1992
DEXTROLYTE II CAPD TRNSFER SET
K920029
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 262d
Cleared Sep 21, 1992
DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET
K920586
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 224d
Cleared Mar 16, 1992
DEXTROLYTE II PERITONEAL DIALYSIS PUMP
K915628
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 90d
Cleared Feb 19, 1992
ABBOTT SMART CAP
K915304
Abbott Laboratories
Gastroenterology & Urology · 90d
Cleared Jul 24, 1991
FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE
K912208
Fresenius USA, Inc.
Gastroenterology & Urology · 65d
Cleared Jan 11, 1991
CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR
K904806
Fresenius USA, Inc.
Gastroenterology & Urology · 79d

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 →