Product code KDJ

Device name: Set, Administration, For Peritoneal Dialysis, Disposable
Medical specialty: Gastroenterology, Urology
Device class: 2
Regulation number: 876.5630
Review panel: GU
Implant: N
Life sustaining/supporting: Y
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K250404	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; s...	Fresenius Medical Care Renal Therapies Group, LLC	2025-04-03
K231849	MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483	Baxter Healthcare	2024-03-12
K214016	15L Cycler Drainage Bag	Baxter Healthcare Corporation	2022-03-18
K192705	MiniCap Extended Life PD Transfer Sets	Baxter Healthcare	2019-10-25
K173593	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•s...	Fresenius Medical Care Renal Therapies Group, LLC	2018-05-21
K173651	Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set	Fresenius Medical Care Renal Therapies Group, LLC	2018-02-14
K173363	Cycler Drain Bag Set	Fresenius Medical Care Renal Therapies Group, LLC	2018-01-24
K151620	Firefly Peritoneal Dialysis Connector Disinfection System	Puracath Medical, Inc.	2016-01-20
K152129	FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution	Baxter Healthcare Corporation	2015-10-29
K152675	EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER	Baxter Healthcare	2015-10-29
K124024	APD LUER-LOCK ADAPTER	Fresensius Medical Care North America	2013-09-19
K083542	FRESENIUS STERILE STAY SAFE CAP	Fresenius Medical Care North America	2008-12-29
K042900	K.E.P. CONNECTOR AND CLIP	K.E.P., LLC	2004-11-05
K041792	FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211	Fresenius Medical Care North America	2004-09-24
K031676	HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q	Baxter Healthcare Corp	2003-11-20
K022412	FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR	Fresenius Medical Care North America	2003-03-05
K974387	PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE	Microwave Medical Systems, Inc.	1999-09-01
K972579	HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE	Baxter Healthcare Corp	1997-10-01
K972731	NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET	Klein-Baker Medical, Inc.	1997-09-29
K963668	MEDISYSTEMS PERITONEAL DIALYSIS SETS	Medisystems Corp.	1997-08-15
K961825	ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493	Baxter Healthcare Corp	1996-08-06
K945567	QC CAP	Medionics International, Inc.	1995-02-07
K930843	RAPID DISCONNECT Y-SET, CAT. NO. 48-7000	National Medical Care, Medical Products Div., Inc.	1994-08-31
K921818	ABBOTT SMART CAP	Abbott Laboratories	1994-03-28
K925403	BAXTER APD 12' EXTENSION LINE	Baxter Healthcare Corp	1994-02-22
K921052	FRESENIUS VARIABLE FILL MONITOR	Fresenius USA, Inc.	1993-02-25
K920586	DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET	National Medical Care, Medical Products Div., Inc.	1992-09-21
K920029	DEXTROLYTE II CAPD TRNSFER SET	National Medical Care, Medical Products Div., Inc.	1992-09-21
K915628	DEXTROLYTE II PERITONEAL DIALYSIS PUMP	National Medical Care, Medical Products Div., Inc.	1992-03-16
K915304	ABBOTT SMART CAP	Abbott Laboratories	1992-02-19

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
08964004471032	Automated PD Set DS-1.B	BYONYKS PRIVATE LIMITED	2025-11-13
08964004471018	Automated PD Set DS-1	BYONYKS PRIVATE LIMITED	2025-09-08
00085412841625	MINICAP EXTENDED LIFE PD TRNS	BAXTER HEALTHCARE CORPORATION	2024-08-05
00085412722894	Cycler Drainage Bag	BAXTER HEALTHCARE CORPORATION	2022-09-23
00085412656021	MiniCap	BAXTER HEALTHCARE CORPORATION	2019-07-22
00085412007748	MiniCap	BAXTER HEALTHCARE CORPORATION	2017-12-21
10887488321462	CARDINAL HEALTH	Cardinal Health 200, LLC	2017-05-01
00085412007403	Locking Titanium Adapter for Peritoneal Dialysis Catheter	BAXTER INTERNATIONAL INC.	2015-10-07
00085412007434	Locking Cap for Peritoneal Dialysis Catheter Adapter	BAXTER INTERNATIONAL INC.	2015-10-07
00085412007694	MINICAP WITH POVIDONE-IODINE SOLUTION	BAXTER HEALTHCARE CORPORATION	2015-10-07
00085412030579	UltraSet CAPD Disposable Disconnect Y-Set	BAXTER INTERNATIONAL INC.	2015-10-07
00085412349145	FlexiCap Disconnect Cap with Povidone-Iodine Solution	BAXTER INTERNATIONAL INC.	2015-10-07
00085412090085	UltraSet CAPD Disposable Disconnect Y-Set	BAXTER HEALTHCARE CORPORATION	2015-10-07
00840861100668	Safe-Lock®	Fresenius Medical Care Holdings, Inc.	2015-10-02
00840861100811	Safe-Lock®	Fresenius Medical Care Holdings, Inc.	2015-10-02
00840861100699	stay.safe®	Fresenius Medical Care Holdings, Inc.	2015-10-02
00840861100767	stay.safe®	Fresenius Medical Care Holdings, Inc.	2015-10-02
00840861100774	stay.safe®	Fresenius Medical Care Holdings, Inc.	2015-10-02
00840861100781	stay.safe®	Fresenius Medical Care Holdings, Inc.	2015-10-02
00840861100798	stay.safe®	Fresenius Medical Care Holdings, Inc.	2015-10-02
00840861100804	stay.safe®	Fresenius Medical Care Holdings, Inc.	2015-10-02
00840861100637	DEL-CLAMP®	Fresenius Medical Care Holdings, Inc.	2015-10-02
00840861100583	stay.safe®	Fresenius Medical Care Holdings, Inc.	2015-10-02
10840861100832	stay.safe®	Fresenius Medical Care Holdings, Inc.	2015-10-02
00085412090092	Manifold Set	BAXTER INTERNATIONAL INC.	2015-09-24
00085412087382	Extension Set with EASY-LOCK Connector	BAXTER INTERNATIONAL INC.	2015-09-24
00085412050867	MiniCap	BAXTER INTERNATIONAL INC.	2015-09-24
00085412007755	APD Drain Manifold	BAXTER INTERNATIONAL INC.	2015-09-24
00085412007731	MiniCap	BAXTER HEALTHCARE CORPORATION	2015-09-24
00085412007410	Cycler Drainage Bag	BAXTER INTERNATIONAL INC.	2015-09-24

Product code KDJ

Related 510(k) Records#

Related GUDID Devices#