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

DTK — Predicate Candidate Screening

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

87 daysmedian FDA review time

332 days90th percentile

83clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K242612	Option ELITE Vena Cava Filter System (352506070E 352506100E)	Argon Medical Devices, Inc.	2024-09-10	7	0
K240578	VenaTech® LP Vena Cava Filter System and VenaTech® Convertib	B.Braun Medical, Inc.	2024-07-31	152	0
K241507	ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.1200	Aln S.A.R.L.	2024-06-26	29	0
K240257	Denali™ Vena Cava Filter System – Femoral and Jugular/Subcla	Bd	2024-02-29	29	0
K233680	Celect Platinum Vena Cava Filter Set for Femoral Vein Approa	William Cook Europe Aps	2024-01-18	63	0
K211874	Günther Tulip Vena Cava Filter Set for Femoral Vein Approach	William Cook Europe Aps	2021-07-28	41	0
K211875	Cook Celect Platinum Vena Cava Filter Set for Femoral Vein A	William Cook Europe Aps	2021-07-28	41	0
K181202	Sentry IVC Filter	Novate Medical , Ltd.	2018-06-06	30	0
K173236	Sentry IVC Filter	Novate Medical , Ltd.	2018-02-22	140	0
K172557	Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach	William Cook Europe Aps	2017-11-20	88	0
K172584	Günther Tulip Vena Cava Filter Set for Femoral Vein Approach	William Cook Europe Aps	2017-11-20	84	0
K163699	ALN Optional Vena Cava Filter - Femoral Approach, ALN Option	Aln Implants Chirurgicaux	2017-09-08	253	0
K171712	Cook Celect Platinum Vena Cava Filter Set for Femoral Vein A	William Cook Europe Aps	2017-08-07	59	0
K162875	Sentry IVC filter	Novate Medical , Ltd.	2017-02-17	126	0
K161218	Gianturco-Roehm Bird’s Nest Vena Cava Filter	Cook Incorporated	2016-07-22	84	0
K160866	Denali Filter System - Femoral Delivery Kit, Denali Filter S	C.R. Bard, Inc.	2016-04-29	30	0
K152765	VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM	B. Braun Interventional Systems, Inc.	2016-02-26	155	0
K143405	Option (TM) ELITE Vena Cava Filter 100cm System	Rex Medical, L.P.	2015-04-16	139	0
K150262	Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter	Volcano Corporation	2015-04-03	58	0
K143208	Denali Filter System - Femoral Delivery Kit, Denali Filter S	C.R. Bard, Inc.	2014-12-09	29	0
K140286	OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER	Cordis, A Johnson & Johnson Co.	2014-03-07	30	0
K133243	OPTION ELITE VENA CAVA FILTER SYSTEM	Rex Medical, L.P.	2013-12-17	56	2
K130366	BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR	C.R. Bard, Inc.	2013-05-15	91	1
K122585	CRUX VENA CAVA FILTER SYSTEM	Crux Biomedical	2013-01-17	146	0
K113124	ALN OPTIONAL VANA CAVA FILTER	Aln Implants Chirurgicaux	2012-11-09	385	0
K120402	CRUX VENA CAVA FILTER SYSTEM	Crux Biomedical	2012-07-13	156	0
K121629	COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROA	William Cook Europe Aps	2012-07-03	29	0
K121057	COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS	William Cook Europe Aps	2012-05-04	28	0
K112119	CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH,	William Cook Europe Aps	2012-03-30	249	0
K112497	MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT	C.R. Bard, Inc.	2011-10-24	56	0
K102511	MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT	C.R. Bard, Inc.	2011-08-24	357	0
K101431	ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVER	C.R. Bard, Inc.	2010-06-25	35	0
K091077	OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER	Cordis Corp., A Johnson & Johnson Co.	2010-02-04	296	2
K093659	ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER S	C.R. Bard, Inc.	2010-01-14	50	0
K081410	OPTION VENA CAVA FILTER	Rex Medical	2009-06-04	380	0
K081138	SAFEFLO VENA CAVA FILTER	Rmt Medical Technilogies, Inc.	2009-05-07	381	0
K090140	GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER	William Cook Europe Aps	2009-04-03	72	0
K082305	G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DE	C.R. Bard, Inc.	2008-10-31	79	0
K080668	G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLA	C.R. Bard, Inc.	2008-07-30	142	0
K073374	COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER	William Cook Europe Aps	2008-03-07	95	0
K073528	VENA CAVA FILTER	Cook Incorporated	2008-02-27	72	0
K070514	ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPR	Aln Implants Chirurgicaux	2008-01-30	342	0
K073090	RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-3	C.R. Bard, Inc.	2008-01-15	75	0
K072240	GUNTHER TULIP VENA CAVA FILTER	Cook, Inc.	2007-11-08	87	0
K061815	COOK CELECT VENA CAVA FILTER	William Cook Europe Aps	2007-04-20	297	0
K063217	VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL)	B.Braun Medical, Inc.	2007-01-12	80	1
K062887	MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL	Bard Peripheral Vascular	2006-10-26	30	0
K052578	BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MOD	Bard Peripheral Vascular, Inc.	2005-11-25	66	2
K050558	MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F	C.R. Bard, Inc.	2005-08-29	179	0
K043509	GUNTHER TULIP VENA CAVA FILTER SET	Cook, Inc.	2005-05-05	136	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