Product Code: KDJ FDA class 2 21 CFR 876.5630

Set, Administration, For Peritoneal Dialysis, Disposable

Gastroenterology, Urology

A disposable peritoneal dialysis administration set is a sterile, single-use assembly of tubing, connectors, and bags used to deliver and drain dialysate into and from the peritoneal cavity in patients with renal failure undergoing peritoneal dialysis as a form of renal replacement therapy. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket clearance. Product code KDJ is regulated under 21 CFR 876.5630 in the Gastroenterology, Urology medical specialty. This device is designated as life-sustaining or life-supporting, reflecting its critical role in renal replacement therapy.

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510(k)s

113

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: KDJ
Device Class: FDA class 2
Regulation Number: 876.5630
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 113 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250404	staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch	Apr 03, 2025	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
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	Mar 12, 2024	Substantially Equivalent	Baxter Healthcare
K214016	15L Cycler Drainage Bag	Mar 18, 2022	Substantially Equivalent	Baxter Healthcare Corporation
K192705	MiniCap Extended Life PD Transfer Sets	Oct 25, 2019	Substantially Equivalent	Baxter Healthcare
K173593	staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch	May 21, 2018	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K173651	Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set	Feb 14, 2018	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K173363	Cycler Drain Bag Set	Jan 24, 2018	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K151620	Firefly Peritoneal Dialysis Connector Disinfection System	Jan 20, 2016	Substantially Equivalent	Puracath Medical, Inc.
K152675	EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER	Oct 29, 2015	Substantially Equivalent	Baxter Healthcare
K152129	FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution	Oct 29, 2015	Substantially Equivalent	Baxter Healthcare Corporation
K124024	APD LUER-LOCK ADAPTER	Sep 19, 2013	Substantially Equivalent	Fresensius Medical Care North America
K083542	FRESENIUS STERILE STAY SAFE CAP	Dec 29, 2008	Substantially Equivalent	Fresenius Medical Care North America
K042900	K.E.P. CONNECTOR AND CLIP	Nov 05, 2004	Substantially Equivalent	K.E.P., LLC
K041792	FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211	Sep 24, 2004	Substantially Equivalent	Fresenius Medical Care North America
K031676	HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q	Nov 20, 2003	Substantially Equivalent	Baxter Healthcare Corp
K022412	FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR	Mar 05, 2003	Substantially Equivalent	Fresenius Medical Care North America
K974387	PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE	Sep 01, 1999	Substantially Equivalent	Microwave Medical Systems, Inc.
K972579	HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE	Oct 01, 1997	Substantially Equivalent	Baxter Healthcare Corp
K972731	NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET	Sep 29, 1997	Substantially Equivalent	Klein-Baker Medical, Inc.
K963668	MEDISYSTEMS PERITONEAL DIALYSIS SETS	Aug 15, 1997	Substantially Equivalent	Medisystems Corp.
K961825	ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493	Aug 06, 1996	Substantially Equivalent	Baxter Healthcare Corp
K945567	QC CAP	Feb 07, 1995	Substantially Equivalent	Medionics International, Inc.
K930843	RAPID DISCONNECT Y-SET, CAT. NO. 48-7000	Aug 31, 1994	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K921818	ABBOTT SMART CAP	Mar 28, 1994	Substantially Equivalent	Abbott Laboratories
K925403	BAXTER APD 12' EXTENSION LINE	Feb 22, 1994	Substantially Equivalent	Baxter Healthcare Corp
K921052	FRESENIUS VARIABLE FILL MONITOR	Feb 25, 1993	Substantially Equivalent	Fresenius USA, Inc.
K920586	DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET	Sep 21, 1992	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K920029	DEXTROLYTE II CAPD TRNSFER SET	Sep 21, 1992	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K915628	DEXTROLYTE II PERITONEAL DIALYSIS PUMP	Mar 16, 1992	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K915304	ABBOTT SMART CAP	Feb 19, 1992	Substantially Equivalent	Abbott Laboratories
K912208	FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE	Jul 24, 1991	Substantially Equivalent	Fresenius USA, Inc.
K904806	CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR	Jan 11, 1991	Substantially Equivalent	Fresenius USA, Inc.
K900295	PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES	Nov 21, 1990	Substantially Equivalent	Microwave Medical Systems, Inc.
K903869	90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET	Nov 20, 1990	Substantially Equivalent	Fresenius/Delmed, Inc.
K902526	CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481	Nov 20, 1990	Substantially Equivalent	Baxter Healthcare Corp
K902451	LONG-LIFE Y-SET CAT. NO. 48-6366-8	Aug 14, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K900106	CLOSED DISCONNECT SYSTEM	Jul 16, 1990	Substantially Equivalent	Delmed, Inc.
K895992	CATHETER EXTENSION SET CAT. NO. 48-3027-9	Mar 23, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K895792	DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6	Mar 23, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K900323	PERITONEAL DIALYSIS CYCLER SET	Mar 22, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K900243	DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1015-6	Mar 22, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K900242	DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3	Mar 22, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K900226	DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1001-6	Mar 22, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K900142	DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1003-2	Mar 22, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K900141	DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1100-6	Mar 22, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K900140	DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET W/3	Mar 22, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K900012	DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET	Mar 22, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K900008	DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET	Mar 22, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K896600	DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1	Mar 22, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K896599	DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET -(8)	Mar 22, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K895991	PERITONEAL DIALYSIS DRAINAGE SET NO. 48-0025-6	Mar 22, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K895990	DEXTROLYTE II PERITONEAL DIALYSIS CYCLER SET	Mar 22, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K900005	DEXTROLYTE II, MANUAL ADMINISTRATION SET 48-1032-1	Mar 02, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K900006	CATHETER ADAPTER SEALING CAP NO. 48-1028-9	Feb 27, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K900004	CONVERTIBLE ADAPTER CATALOG NO. 48-4039-3	Feb 27, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K896956	QUICK DISCONNECT CLAMP CATALOG NO. 48-0300-3	Feb 27, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K896764	UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5	Feb 26, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K896763	CATHETER ADAPTER CO-PAK CATALOG NO. 48-0122-1	Feb 26, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K896761	TRANSFER SET SEALING CAP, CAT. NO. 48-1027-1	Feb 26, 1990	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K895673	CONNECTION SHIELDS CODES 5C4213 AND 5C4215	Jan 29, 1990	Substantially Equivalent	Baxter Healthcare Corp
K895631	DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466	Jan 29, 1990	Substantially Equivalent	Baxter Healthcare Corp
K894783	PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP	Sep 07, 1989	Substantially Equivalent	Baxter Healthcare Corp
K893712	PERITONEAL DIALYSIS SYSTEM AND ACCESS.	Jul 24, 1989	Substantially Equivalent	Delmed, Inc.
K893231	DELCLAMP	Jun 08, 1989	Substantially Equivalent	Delmed, Inc.
K892872	PERITONEAL DIALYSIS CYCLER SET W/12 PRONG MANIFOLD	May 18, 1989	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K892871	PERITONEAL DIALYSIS CYCLER SET, W/8 PRONG MANIFOLD	May 18, 1989	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K892870	PERITONEAL DIALYSIS CYCLER SET, W/5 PRONG MANIFOLD	May 18, 1989	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K883393	CAPD DISPOSABLE Y SYSTEM - DY SET	Nov 03, 1988	Substantially Equivalent	Medionics International , Ltd.
K883239	CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS	Oct 21, 1988	Substantially Equivalent	Baxter Healthcare Corp
K882498	EXTENDED LIFE CAPD TRANSFER SET 5C4444	Jul 13, 1988	Substantially Equivalent	Baxter Healthcare Corp
K882455	EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC4373	Jul 13, 1988	Substantially Equivalent	Baxter Healthcare Corp
K873984	AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)	Oct 20, 1987	Substantially Equivalent	Travenol Laboratories, S.A.
K871155	DELFLEX RIGID DRAIN CONTAINER	Jul 16, 1987	Substantially Equivalent	Delmed, Inc.
K871583	MODIFIED LABELING FOR AMUKIN-50%	Jul 09, 1987	Substantially Equivalent	Amuchina Intl., Inc.
K870626	FREEDOM SET II WITH TRIFLEX VALVE	Jun 03, 1987	Substantially Equivalent	Delmed, Inc.
K871154	DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICE	Apr 30, 1987	Substantially Equivalent	Delmed, Inc.
K871050	CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM.	Apr 10, 1987	Substantially Equivalent	Abbott Laboratories
K871049	CAPD Y-ADMIN. SET USED W/INPERSOL BIOCAP ADMIN.	Apr 10, 1987	Substantially Equivalent	Abbott Laboratories
K870145	EXTERNAL Y VALVE 5C4198	Mar 10, 1987	Substantially Equivalent	Travenol Laboratories, S.A.
K860700	CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C4186	Apr 07, 1986	Substantially Equivalent	Travenol Laboratories, S.A.
K860230	CAPD TRANSFER SET SPIKE 5C4363	Feb 05, 1986	Substantially Equivalent	Travenol Laboratories, S.A.
K853550	TRAVENOL CAPD Y SET 5C4354	Oct 04, 1985	Substantially Equivalent	Travenol Laboratories, S.A.
K852678	CAPD TRANSFER SET FOR REDUCED FILL VOLUMES 5C4353	Jul 29, 1985	Substantially Equivalent	Travenol Laboratories, S.A.
K851208	COMPACT EXCHANGE DEVICE 5C4197	Apr 08, 1985	Substantially Equivalent	Travenol Laboratories, S.A.
K851207	EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153	Apr 08, 1985	Substantially Equivalent	Travenol Laboratories, S.A.
K820546	CARD U.V. GERMICIDAL CHAMBER II	Jun 30, 1982	Substantially Equivalent	Travenol Laboratories, S.A.
K812802	CAPD U.V. GERMICIDAL CONNECTION SYSTEM	Mar 02, 1982	Substantially Equivalent	Travenol Laboratories, S.A.
K813069	PERITONEAL DIALYSIS CYCLER SET	Nov 16, 1981	Substantially Equivalent	American Medical Products, Inc.
K812772	PERITONEAL DIALYSIS CYCLER SET (8UNIT)	Oct 19, 1981	Substantially Equivalent	Dravon Medical, Inc.
K812771	PERITONEAL DIALYSIS DRAINAGE	Oct 19, 1981	Substantially Equivalent	Dravon Medical, Inc.
K811863	STERI-TRACT	Sep 21, 1981	Substantially Equivalent	Rogo Ent.
K812130	SPIKE GUARD	Sep 09, 1981	Substantially Equivalent	Clinipad Corp.
K811294	GAMBRO PERITONEAL DIALYSIS FLUID LINES	Jun 12, 1981	Substantially Equivalent	Gambro, Inc.
K810840	AMP PERITONEAL DIALYSIS PREP KIT	Apr 29, 1981	Substantially Equivalent	American Medical Products, Inc.
K810671	CCPD 3 LITER DRAINAGE SET	Mar 24, 1981	Substantially Equivalent	American Medical Products, Inc.
K810670	CCPD CYCLER SET	Mar 24, 1981	Substantially Equivalent	American Medical Products, Inc.
K810600	CAPD EXCHANGE SET	Mar 24, 1981	Substantially Equivalent	American Mcgaw
K803300	INPERSOL CAPD BAG PORT CLAMP	Jan 29, 1981	Substantially Equivalent	Abbott Laboratories
K801881	INPERSOL-CAPD ADMINISTRATION SET	Oct 10, 1980	Substantially Equivalent	Abbott Laboratories
K801220	PERITONEAL DIALYSIS CYCLER SET W/PUMP	Aug 12, 1980	Substantially Equivalent	American Medical Products, Inc.
K801193	CLIRANS TE15 HOLLOW FIBER DIALYZER	Aug 12, 1980	Substantially Equivalent	Terumo America, Inc.
K800993	INPERSOL CAPD ADMIN. SET & CATHETER ADAP	Aug 12, 1980	Substantially Equivalent	Abbott Laboratories
K792651	CAPD TRANSFER SET JC9044	Feb 06, 1980	Substantially Equivalent	Travenol Laboratories, S.A.
K791512	CONTINUOUS AMBULATORY DIALYSIS (CAPD)	Feb 06, 1980	Substantially Equivalent	Norton Performance Plastics Corp.
K791722	DISPOSABLE PERITONEAL DIALYSIS EXTENSION	Nov 16, 1979	Substantially Equivalent	American Medical Products, Inc.
K791899	CYCLER SETS MOD. #5C4143, 5C4144, 5C4145	Nov 13, 1979	Substantially Equivalent	Travenol Laboratories, S.A.
K791426	PERITONEAL PAC	Aug 28, 1979	Substantially Equivalent	Intermed, Inc.
K781755	DAP-PAK	Feb 15, 1979	Substantially Equivalent	Dravon Medical, Inc.
K780957	SET, ADMINISTRATION, MANUAL, DIALYSIS	Jul 06, 1978	Substantially Equivalent	American Medical Products, Inc.
K780082	PERITONEAL DIALYSIS ADMIN. SET	Jan 24, 1978	Substantially Equivalent	Physio-Control Corp.
K772236	FILTER, PERITONEAL DIALY. ADMIN. SET	Jan 24, 1978	Substantially Equivalent	Millipore Corp.
K771482	RINSE BLOCK CONNECTOR	Jan 03, 1978	Substantially Equivalent	Quinton, Inc.
K772136	PERITONEAL CYCLER & MANIFOLD SET	Dec 20, 1977	Substantially Equivalent	Physio-Control Corp.