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

MPB — Predicate Candidate Screening

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

205 daysmedian FDA review time

463 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K250836	14F Duo-Flow® Side X Side Double Lumen Catheter	Medical Components, Inc.	2025-08-12	145	0
K200426	Acute Dual Lumen Hemodialysis Catheter	Health Line International Corporation	2020-12-24	307	0
K192807	Duo-Flow Side x Side Double Lumen Catheter	Medical Components, Inc. (dba MedComp)	2020-04-23	205	0
K192302	Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lu	Covidien, LLC	2020-01-17	147	6
K163458	Zenysis Short-Term Dialysis Catheter	C.R. Bard, Inc.	2017-04-04	116	0
K161504	Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray	Cook Incorporated	2017-01-06	219	0
K153190	Zenysis Short-Term Dialysis Catheter	C.R. Bard, Inc.	2016-01-05	63	0
K122091	COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK	Cook, Inc.	2013-07-29	378	0
K120674	MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE	Covidien	2012-04-04	30	1
K110793	AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSI	Ameco Medical Industries	2011-12-16	269	0
K102833	DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS	Foshan Nanhai Bai HE Medical Technology Co., Ltd.	2011-11-18	415	0
K100451	GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J	Gambro Renal Products, Inc.	2010-12-21	307	0
K090102	NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXT	C.R. Bard, Inc.	2009-02-12	28	0
K071145	NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE	Nipro Medical Corporation	2007-09-07	136	1
K063355	D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW	Novosci Corp.	2007-07-27	262	0
K070234	JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS	Jms North America Corp.	2007-05-22	126	0
K040301	GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A	Gambro Renal Products	2004-11-01	266	0
K030268	NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORA	C.R. Bard, Inc.	2003-07-30	184	1
K030209	MAHURKAR OPLUS CATHETER, MODEL 13.5 FR	The Kendall Company	2003-05-13	112	3
K022221	TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETE	Deltec, Inc.	2003-01-30	205	0
K010778	NIAGARA SLIM-CATH	C.R. Bard, Inc.	2001-04-13	29	0
K001958	KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER.	Keystone Medical	2000-09-25	90	0
K993933	14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLE	Arrow Intl., Inc.	2000-09-14	301	3
K991320	MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN	Medical Components, Inc.	1999-11-10	205	0
K980438	11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20	Medical Components, Inc.	1999-06-10	491	0
K983511	SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE	Medical Components, Inc.	1999-06-08	244	0
K991431	14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT	Arrow Intl., Inc.	1999-05-26	30	1
K984022	PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT	Arrow Intl., Inc.	1999-05-18	187	1
K974236	MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF14	Medical Components, Inc.	1999-04-15	519	0
K965178	NIAGARA DUAL LUMEN CATHETER	Vas-Cath, Inc.	1997-08-19	238	0
K963446	KENDALL DUAL LUMEN CATHETER	Kendall Healthcare Products Co. Div.Of Tyco Health	1997-03-18	196	0
K952660	BRAUN HEMODIALYSIS CATHETER	B.Braun Medical, Inc.	1996-09-17	463	0
K955002	MAHURKAR 8 FR DUAL LEMEN CATHETER	Quinton, Inc.	1996-09-13	317	0
K923691	TWIN SILICONE CATHETER	Medical Components, Inc.	1995-09-25	1159	0
K896252	MODIFIED QUINTON SINGLE LUMEN CATHETER	Quinton, Inc.	1990-01-29	91	0
K893188	QUINTON SINGLE LUMEN CATHETER	Quinton, Inc.	1989-06-08	34	0
K880583	MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH	Quinton, Inc.	1988-02-22	13	0
K871360	10F & 11.5F MAHURKAR DUAL LUMEN CATHETERS, USEABLE	Quinton, Inc.	1987-04-29	23	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