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

AngioDynamics, Inc. — Predicate Candidate Screening

87 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

79 daysmedian FDA review time

238 days90th percentile

87clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252509	AlphaVac Multipurpose Mechanical Aspiration System F1885	AngioDynamics, Inc.	2025-11-24	108	0
K253106	AngioVac Cannula	AngioDynamics, Inc.	2025-10-24	30	0
K242687	NanoKnife Generator (H78720300301US0); NanoKnife Single Elec	AngioDynamics, Inc.	2024-12-06	91	0
K240397	AlphaVac MMA F1885 System (H787253020)	AngioDynamics, Inc.	2024-04-01	52	0
K231945	VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT Never	AngioDynamics, Inc.	2023-07-20	20	0
K223581	Solero Microwave Tissue Ablation (MTA) System and Accessorie	AngioDynamics, Inc.	2023-03-27	116	0
K221883	Solero Microwave Tissue Ablation (MTA) System and Accessorie	AngioDynamics, Inc.	2023-03-07	251	0
K213388	AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 Syst	AngioDynamics, Inc.	2022-04-04	172	0
K213067	Solero Microwave Tissue Ablation (MTA) System and Accessorie	AngioDynamics, Inc.	2021-12-03	71	0
K212386	AngioVac F18 85	AngioDynamics, Inc.	2021-09-30	59	0
K211081	AlphaVac Multipurpose Mechanical Aspiration (MMA) System	AngioDynamics, Inc.	2021-06-04	53	0
K202347	UNIFUSE Infusion System with Cooper Wire	AngioDynamics, Inc.	2020-09-15	28	0
K192864	UNI*FUSE Infusion System with Cooper Wire	AngioDynamics, Inc.	2020-06-01	238	0
K190559	SmartPort+ Implantable Ports, SmartPort Plastic Implantable	AngioDynamics, Inc.	2020-05-22	444	0
K190594	AngioVac C20, AngioVac C180	AngioDynamics, Inc.	2019-07-05	120	0
K182250	Solero MTA Cart, Solero MTA System, Solero microwave Tissue	AngioDynamics, Inc.	2019-02-28	192	0
K173762	AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Cathete	AngioDynamics, Inc.	2018-07-18	219	18
K181044	400um Perforator and Accessory Vein Ablation Kit	AngioDynamics, Inc.	2018-07-05	77	0
K171921	VenaCure EVLT NeverTouch Procedure Kit	AngioDynamics, Inc.	2017-08-24	58	0
K170775	Mini Stick ENVI Non-Vascular Introducer Kit	AngioDynamics, Inc.	2017-07-19	127	0
K170695	VenaCure EVLT NeverTouch Direct Introducer Sheath	AngioDynamics, Inc.	2017-05-30	84	0
K163356	Pulse* Spray Infusion System, Uni*Fuse Infusion System	AngioDynamics, Inc.	2017-05-30	181	1
K162449	Solero MTA System, Solero Microwave Tissue Ablation Applicat	AngioDynamics, Inc.	2017-05-05	246	0
K161596	Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters	AngioDynamics, Inc.	2017-04-28	323	20
K170743	AngioDynamics Total Abscession Biliary Drainage Catheter	AngioDynamics, Inc.	2017-03-30	20	0
K170258	SpeedLyser Infusion Catheter Kit	AngioDynamics, Inc.	2017-02-21	25	0
K163141	NAMIC ClearaCIL Contrast Injection Lines	AngioDynamics, Inc.	2017-01-06	58	0
K162914	VenaCure EVLT NeverTouch Procedure Kit	AngioDynamics, Inc.	2016-11-16	30	0
K151724	AngioDynamics Mariner Angiographic Catheters	AngioDynamics, Inc.	2015-10-14	110	0
K150089	NanoKnife System	AngioDynamics, Inc.	2015-06-18	153	0
K142889	Celerity PICC Tip Confirmation System	AngioDynamics, Inc.	2015-01-27	116	1
K142593	AngioVac Cannula	AngioDynamics, Inc.	2014-11-12	58	0
K142614	AngioDynamics VenaCure EVLT Tre’ Sheath and VenaCure EVLT Ne	AngioDynamics, Inc.	2014-10-10	24	0
K133561	VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' S	AngioDynamics, Inc.	2013-12-19	29	0
K130671	VENACURE EVLT NEVERTOUCH PROCEDURE KIT	AngioDynamics, Inc.	2013-03-26	14	0
K112452	ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS	AngioDynamics, Inc.	2012-03-30	218	20
K112600	ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT	AngioDynamics, Inc.	2012-01-30	145	0
K102329	NANOKNIFE SYSTEM	AngioDynamics, Inc.	2011-10-24	433	1
K110936	DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT	AngioDynamics, Inc.	2011-06-10	67	6
K110225	ANGIODYNAMICS, INC. VENACURE 1470 LASER	AngioDynamics, Inc.	2011-05-13	108	0
K102796	ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT	AngioDynamics, Inc.	2010-12-15	79	16
K100199	ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVL	AngioDynamics, Inc.	2010-11-26	308	0
K101843	DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT	AngioDynamics, Inc.	2010-10-20	111	30
K101017	ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEM	AngioDynamics, Inc.	2010-06-17	66	0
K093406	MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 121	AngioDynamics, Inc.	2010-03-25	143	38
K081472	SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TIT	AngioDynamics, Inc.	2008-09-23	119	1
K080287	ONCOBIONIC BIPOLAR ELECTRODE	AngioDynamics, Inc.	2008-07-03	150	0
K080451	UNIBLATE ELECTROSURGICAL DEVICE	AngioDynamics, Inc.	2008-07-03	135	0
K080400	ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCE	AngioDynamics, Inc.	2008-05-13	90	5
K073464	ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE	AngioDynamics, Inc.	2008-01-23	44	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