Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

KDJ — Predicate Candidate Screening

113 FDA 510(k) clearances under this product code; the 50 most recent screened below.

77 daysmedian FDA review time

224 days90th percentile

113clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K250404	stay•safe® catheter extension set with Safe- Lock, 12 inch;	Fresenius Medical Care Renal Therapies Group, LLC	2025-04-03	50	0
K231849	MiniCap Extended Life PD Transfer Set with Twist Clamp - Cod	Baxter Healthcare	2024-03-12	263	0
K214016	15L Cycler Drainage Bag	Baxter Healthcare Corporation	2022-03-18	86	0
K192705	MiniCap Extended Life PD Transfer Sets	Baxter Healthcare	2019-10-25	28	2
K173593	stay•safe catheter extension set with Safe-Lock, 12 inch, st	Fresenius Medical Care Renal Therapies Group, LLC	2018-05-21	181	5
K173651	Multiple Tubing Segment Set with stay safe PIN Connectors, s	Fresenius Medical Care Renal Therapies Group, LLC	2018-02-14	78	0
K173363	Cycler Drain Bag Set	Fresenius Medical Care Renal Therapies Group, LLC	2018-01-24	90	0
K151620	Firefly Peritoneal Dialysis Connector Disinfection System	Puracath Medical, Inc.	2016-01-20	218	0
K152129	FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniC	Baxter Healthcare Corporation	2015-10-29	90	1
K152675	EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIU	Baxter Healthcare	2015-10-29	41	2
K124024	APD LUER-LOCK ADAPTER	Fresensius Medical Care North America	2013-09-19	265	0
K083542	FRESENIUS STERILE STAY SAFE CAP	Fresenius Medical Care North America	2008-12-29	31	1
K042900	K.E.P. CONNECTOR AND CLIP	K.E.P., LLC	2004-11-05	17	0
K041792	FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211	Fresenius Medical Care North America	2004-09-24	84	0
K031676	HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4	Baxter Healthcare Corp	2003-11-20	174	2
K022412	FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH	Fresenius Medical Care North America	2003-03-05	224	5
K974387	PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES,	Microwave Medical Systems, Inc.	1999-09-01	649	0
K972579	HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, H	Baxter Healthcare Corp	1997-10-01	83	0
K972731	NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET	Klein-Baker Medical, Inc.	1997-09-29	69	0
K963668	MEDISYSTEMS PERITONEAL DIALYSIS SETS	Medisystems Corp.	1997-08-15	336	0
K961825	ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 &	Baxter Healthcare Corp	1996-08-06	88	0
K945567	QC CAP	Medionics International, Inc.	1995-02-07	133	0
K930843	RAPID DISCONNECT Y-SET, CAT. NO. 48-7000	National Medical Care, Medical Products Div., Inc.	1994-08-31	559	0
K921818	ABBOTT SMART CAP	Abbott Laboratories	1994-03-28	712	0
K925403	BAXTER APD 12' EXTENSION LINE	Baxter Healthcare Corp	1994-02-22	487	0
K921052	FRESENIUS VARIABLE FILL MONITOR	Fresenius USA, Inc.	1993-02-25	357	0
K920586	DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET	National Medical Care, Medical Products Div., Inc.	1992-09-21	224	0
K920029	DEXTROLYTE II CAPD TRNSFER SET	National Medical Care, Medical Products Div., Inc.	1992-09-21	262	0
K915628	DEXTROLYTE II PERITONEAL DIALYSIS PUMP	National Medical Care, Medical Products Div., Inc.	1992-03-16	90	0
K915304	ABBOTT SMART CAP	Abbott Laboratories	1992-02-19	90	0
K912208	FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE	Fresenius USA, Inc.	1991-07-24	65	0
K904806	CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR	Fresenius USA, Inc.	1991-01-11	79	0
K900295	PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES	Microwave Medical Systems, Inc.	1990-11-21	303	0
K902526	CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481	Baxter Healthcare Corp	1990-11-20	168	0
K903869	90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET	Fresenius/Delmed, Inc.	1990-11-20	90	0
K902451	LONG-LIFE Y-SET CAT. NO. 48-6366-8	National Medical Care, Medical Products Div., Inc.	1990-08-14	74	0
K900106	CLOSED DISCONNECT SYSTEM	Delmed, Inc.	1990-07-16	188	0
K895992	CATHETER EXTENSION SET CAT. NO. 48-3027-9	National Medical Care, Medical Products Div., Inc.	1990-03-23	161	0
K895792	DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6	National Medical Care, Medical Products Div., Inc.	1990-03-23	176	0
K900323	PERITONEAL DIALYSIS CYCLER SET	National Medical Care, Medical Products Div., Inc.	1990-03-22	58	0
K896599	DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET -(8)	National Medical Care, Medical Products Div., Inc.	1990-03-22	121	0
K900243	DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1015-6	National Medical Care, Medical Products Div., Inc.	1990-03-22	64	0
K900141	DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1100-6	National Medical Care, Medical Products Div., Inc.	1990-03-22	70	0
K895990	DEXTROLYTE II PERITONEAL DIALYSIS CYCLER SET	National Medical Care, Medical Products Div., Inc.	1990-03-22	160	0
K900012	DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET	National Medical Care, Medical Products Div., Inc.	1990-03-22	79	0
K900008	DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET	National Medical Care, Medical Products Div., Inc.	1990-03-22	79	0
K900242	DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3	National Medical Care, Medical Products Div., Inc.	1990-03-22	64	0
K895991	PERITONEAL DIALYSIS DRAINAGE SET NO. 48-0025-6	National Medical Care, Medical Products Div., Inc.	1990-03-22	160	0
K896600	DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1	National Medical Care, Medical Products Div., Inc.	1990-03-22	121	0
K900142	DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1003-2	National Medical Care, Medical Products Div., Inc.	1990-03-22	70	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda