Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

MSD — Predicate Candidate Screening

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

105 daysmedian FDA review time

273 days90th percentile

124clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K241581	Hemodialysis Catheter	Haolang Medical USA Corporation	2025-05-16	347	0
K210461	End Cap	Medical Components Inc (Medcomp)	2021-09-14	210	0
K203575	GlidePath Retro Long-Term Hemodialysis Catheter	C.R. Bard, Inc.	2021-07-01	206	0
K211410	GlidePath 13F Long-Term Hemodialysis Catheter	Bard Peripheral Vascular, Inc.	2021-06-04	29	0
K203767	Pristine Long-Term Hemodialysis Catheter	C B Bard, Inc.	2021-04-02	100	0
K202150	GlidePath 7.5F Long-Term Dialysis Catheter	C.R. Bard, Inc.	2020-11-18	107	0
K202176	Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sidehole	Medical Components, Inc. (dba MedComp)	2020-09-03	30	0
K200627	GlidePath 10F Long-Term Dialysis Catheter	C.R. Bard, Inc.	2020-06-22	104	0
K190527	GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Te	C. R. Bard	2020-03-05	367	0
K182443	Pristine Hemodialysis Catheter	Pristine Access Technologies , Ltd.	2019-05-31	266	0
K173667	15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with	Medical Components, Inc. (dba MedComp)	2018-05-17	168	0
K173805	NexSite HD Hemodialysis Symmetric Tip Catheter for long term	Marvao Medical Devices, Ltd.	2018-02-08	55	0
K171571	NexSite HD, Hemodialysis Step Tip Catheter (60cm)	Marvao Medical Devices, Ltd.	2017-11-30	184	0
K171618	Symetrex Long Term Hemodialysis Catheter	Medcomp (Dba Medical Components, Inc.)	2017-11-16	167	0
K161026	NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use	Marvao Medical Devices, Ltd.	2016-08-09	119	0
K151967	Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Ter	Merit Medical Systems, Inc.	2016-04-04	263	1
K143567	NexSite HD Hemodialysis Split Tip Catheter for long term use	Marvao Medical Devices, Ltd.	2015-03-31	105	0
K140884	SYMETREX LONG TERM HEMODIALYSIS CATHETER	Phase One Medical	2014-11-26	233	0
K140492	NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE	Marvao Medical Devices, Ltd.	2014-11-13	259	0
K141051	VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGR	Arrow International, Inc.	2014-07-07	74	1
K141363	CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TER	Merit Medical Systems, Inc.	2014-06-18	26	0
K130889	SPLIT CATH RG	Medcomp	2014-04-28	395	0
K131260	NMI DIALYSIS CATHETER	Navilyst Medical, Inc.	2014-02-14	288	2
K133796	NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM),	Marvao Medical Devices, Ltd.	2014-01-31	49	0
K130851	CASCADE HEMODIALYSIS/APHERESIS CATHETER	Health Line International Corporation	2014-01-09	288	0
K131814	AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER	Ameco Medical Industries	2013-07-26	36	0
K130192	NEXTSTEP RETROGRADE	Arrow International, Inc.	2013-05-10	105	0
K123943	AMECATH DUAL LUMEN HEMODIALYSIS CATHETER	Ameco Medical Industries	2013-04-02	103	0
K121933	NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NE	Marvao Medical Devices, Ltd.	2013-03-14	255	0
K123196	PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISIO	Covidien	2013-01-31	112	44
K121848	SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM	Medical Components, Inc.	2012-09-21	88	1
K113487	HEMO-CATH 10F, HEMO-CATH 12.5F	Medical Components, Inc.	2012-03-09	107	0
K111651	SPLIT CATH III	Medical Components, Inc.	2011-12-08	178	1
K111817	PALINDROME RT CHRONIC CATHETER	Covidien	2011-08-30	64	0
K111900	NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER	Teleflexmedical, Inc.	2011-08-17	43	2
K111372	TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHU	Covidien	2011-08-04	80	3
K111117	CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC H	Teleflexmedical, Inc.	2011-06-30	70	4
K110936	DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT	AngioDynamics, Inc.	2011-06-10	67	6
K102238	ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER	Teleflexmedical, Inc.	2011-02-01	176	1
K102043	ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER	Rex Medical	2010-11-18	121	3
K101843	DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT	AngioDynamics, Inc.	2010-10-20	111	30
K100169	DURASPAN HEMODIALYSIS LONG-TERM CATHETER	R4 Vascular, Inc.	2010-02-18	29	1
K091506	DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 6	R4 Vascular, Inc.	2010-01-08	232	1
K092597	CENTROS CHRONIC HEMODIALYSIS CATHETER SET	Ash Access Technology, Inc.	2009-11-12	80	0
K092205	PALINDROME P HEMODIALYSIS CATHETER	Covidien Lp, Formerly Registered AS Kendall	2009-10-30	100	0
K091760	DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS)	Dermaport, Inc.	2009-07-20	34	0
K090528	DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM	C.R. Bard, Inc.	2009-05-28	90	0
K090148	PROGUIDE CHRONIC DIALYSIS CATHETER	Merit Medical Systems, Inc.	2009-04-13	82	1
K090101	EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS	C.R. Bard, Inc.	2009-02-10	26	0
K080400	ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCE	AngioDynamics, Inc.	2008-05-13	90	5

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