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

Volcano Corporation — Predicate Candidate Screening

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

65 daysmedian FDA review time

174 days90th percentile

55clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K210235	Verrata PLUS Pressure Guide Wire	Volcano Corporation	2021-04-15	77	0
K203719	IntraSight Mobile	Volcano Corporation	2021-01-19	29	0
K202543	OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire	Volcano Corporation	2020-09-28	26	0
K192886	OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire	Volcano Corporation	2020-03-26	168	0
K190626	SyncVision System	Volcano Corporation	2019-04-12	32	0
K190078	IntraSight	Volcano Corporation	2019-02-11	26	0
K173860	s5 Intravascular Ultrasound Imaging and Pressure Systems, s5	Volcano Corporation	2018-04-11	112	0
K172455	CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit,	Volcano Corporation	2017-10-25	72	1
K172574	SyncVision System	Volcano Corporation	2017-10-05	38	0
K170385	CORE M2 Vascular System	Volcano Corporation	2017-04-06	57	0
K160583	REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS	Volcano Corporation	2016-10-26	239	2
K161887	Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verra	Volcano Corporation	2016-09-20	71	0
K161756	SyncVision System	Volcano Corporation	2016-09-05	70	0
K153094	Visions PV .035 Digital IVUS Catheter	Volcano Corporation	2015-12-31	66	0
K153369	SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE,	Volcano Corporation	2015-12-22	29	0
K152582	CORE FM System, Patient Interface Module (OPIM), Hemodynamic	Volcano Corporation	2015-12-03	84	0
K152829	Visions PV.014P RX Digital IVUS Catheter	Volcano Corporation	2015-11-19	51	1
K150442	Volcano Visions PV .018 Digital IVUS Catheter	Volcano Corporation	2015-09-04	196	1
K143701	EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CA	Volcano Corporation	2015-08-26	245	0
K151904	SyncVision System	Volcano Corporation	2015-07-31	18	0
K150262	Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter	Volcano Corporation	2015-04-03	58	0
K150441	Volcano iFR Modality, iFR Scout feature	Volcano Corporation	2015-03-20	28	0
K143122	Volcano iFR Harvest Software (Offline)	Volcano Corporation	2015-02-20	112	0
K133323	VOLCANO IFR MODALITY	Volcano Corporation	2014-03-14	136	0
K140291	VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I IN	Volcano Corporation	2014-03-07	30	0
K133681	CRUX SNARE FILTER RETRIEVAL SET	Volcano Corporation	2014-01-30	59	0
K133641	CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE	Volcano Corporation	2013-12-20	23	0
K132558	SYNC-RX SYSTEM	Volcano Corporation	2013-12-12	119	0
K133142	VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOL	Volcano Corporation	2013-11-15	29	0
K132659	VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM	Volcano Corporation	2013-09-27	32	0
K131288	VERRATA PRESSURE GUIDE WIRE	Volcano Corporation	2013-06-21	46	0
K123482	REFLOW ASPIRATION CATHETER	Volcano Corporation	2013-04-29	167	0
K122826	PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PRE	Volcano Corporation	2013-04-24	222	0
K123898	VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE	Volcano Corporation	2013-01-14	27	8
K121273	VISIONS PV .035 DITITAL IVUS CATHETER	Volcano Corporation	2012-09-10	136	1
K120697	EAGLE EYE PLATINUM ST CATHETER	Volcano Corporation	2012-04-05	29	0
K113486	VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SY	Volcano Corporation	2012-01-27	65	0
K112035	VALET MICRO CATHETER	Volcano Corporation	2012-01-05	174	0
K111395	PRIMEWIRE PRESTIGE PLUS	Volcano Corporation	2011-08-01	74	1
K111706	VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM	Volcano Corporation	2011-07-15	28	1
K100930	PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J,	Volcano Corporation	2010-04-30	25	0
K092596	EAGLE EYE PLATINUM DIGITAL IVUS CATHETER	Volcano Corporation	2009-12-10	108	0
K082229	S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COM	Volcano Corporation	2008-10-08	62	3
K080891	REVOLUTION 45MHZ IVUS IMAGING CATHETER	Volcano Corporation	2008-05-12	42	0
K073473	EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/	Volcano Corporation	2008-01-14	34	0
K071554	VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM	Volcano Corporation	2008-01-04	211	0
K071660	VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MO	Volcano Corporation	2007-08-31	74	0
K070487	SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX	Volcano Corporation	2007-03-16	24	0
K061215	VOLCANO S51 FAMILY OF IMAGING SYSTEMS	Volcano Corporation	2006-08-10	100	0
K060483	VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM	Volcano Corporation	2006-06-23	119	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