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

St Jude Medical · Predicate Candidate Screening

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

65 daysmedian FDA review time

184 days90th percentile

105clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K181382	GuardianTM Burr Hole Cover System	St Jude Medical	2018-07-20	56	0
K172396	EnSite Velocity Cardiac Mapping System v5.2	St Jude Medical	2018-04-23	258	0
K173232	myMerlin(TM) Mobile Application Model APP1001	St Jude Medical	2017-11-02	29	0
K160335	Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 5	St Jude Medical	2016-12-13	309	0
K162643	MediGuide Technology System	St Jude Medical	2016-12-13	82	0
K160218	AutoMark Module	St Jude Medical	2016-12-13	319	0
K160210	EnSite Precision Cardiac Mapping System v2.0	St Jude Medical	2016-12-13	320	0
K161873	Pacel Flow Directed Pacing Catheter	St Jude Medical	2016-11-22	138	0
K160187	Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap	St Jude Medical	2016-10-21	268	0
K160186	EnSite Velocity Surface Electrode Kit	St Jude Medical	2016-10-07	254	0
K152342	Guardian Burr Hole Cover System, Guardian Screw, Burr Hole C	St Jude Medical	2016-06-09	295	0
K152784	Pacel Bipolar Pacing Catheters	St Jude Medical	2015-10-22	27	0
K151911	WorkMate Claris System, WorkMate Claris System Display Plus	St Jude Medical	2015-10-22	101	0
K151622	St.Jude Medical MediGuide Enabled Livewire Steerable Electro	St Jude Medical	2015-07-15	29	0
K150631	St. Jude Medical MediGuide Enabled Livewire Steerable Electr	St Jude Medical	2015-04-01	21	0
K142239	CPS Direct MediGuide Enabled outer catheter	St Jude Medical	2014-12-18	127	0
K142235	CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide	St Jude Medical	2014-12-18	127	0
K142254	CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide T	St Jude Medical	2014-11-13	91	0
K141050	ENSITE VELOCITY SYSTEM	St Jude Medical	2014-06-06	44	0
K140272	SWIFT-LOCK ANCHOR	St Jude Medical	2014-05-02	88	0
K140327	ULTIMUM EV HEMOSTASIS INTRODUCER	St Jude Medical	2014-03-11	29	0
K132073	EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE	St Jude Medical	2013-09-09	68	0
K130727	ENSITE VELOCITY SYSTEM	St Jude Medical	2013-08-29	164	0
K131063	AMPLATZER TORQ VUE LP DELIVERY SYSTEM	St Jude Medical	2013-08-15	121	1
K130545	MULTI LEAD TRIAL CABLE	St Jude Medical	2013-06-18	109	0
K130594	ENSITE VELOCITY SYSTEM	St Jude Medical	2013-05-03	57	0
K130257	CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER	St Jude Medical	2013-03-20	47	0
K130252	CPS AIM UNIVERSAL SLITTABLE INNER CATHETER	St Jude Medical	2013-03-20	47	0
K122587	BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206,	St Jude Medical	2013-02-07	167	0
K122161	SJM CONFIRM	St Jude Medical	2012-11-28	131	0
K121381	VIEWFLEX XTRA ICE CATHETER	St Jude Medical	2012-06-07	30	0
K121006	ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER	St Jude Medical	2012-05-03	30	0
K113611	RAPID PROGRAMMER	St Jude Medical	2012-04-20	136	0
K120544	RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN	St Jude Medical	2012-03-19	25	0
K113584	PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEI	St Jude Medical	2012-03-02	88	0
K113773	ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL	St Jude Medical	2012-01-18	27	0
K112688	ENSITE VELOCITY SYSTEM V.3.0	St Jude Medical	2011-11-09	55	0
K110609	EPIDUCER LEAD DELIVERY SYSTEM	St Jude Medical	2011-06-24	113	0
K111092	ENGAGE/ENGAGE TR INTRODUCERS	St Jude Medical	2011-06-09	51	0
K110450	AGILIS NXT STEERABLE INTRODUCER	St Jude Medical	2011-05-10	83	0
K110549	ENSITE VELOCITY SYSTEM	St Jude Medical	2011-05-05	69	0
K103083	AGILIS ES STEERABLE INTRODUCER	St Jude Medical	2011-04-08	171	0
K110085	VANTAGE VIEW SYSTEM	St Jude Medical	2011-01-26	15	0
K102721	LIVEWIRE ELECTOPHYSIOLOGY CATHETER	St Jude Medical	2010-10-18	27	0
K101955	ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTRO	St Jude Medical	2010-10-15	95	0
K101697	ENSITE VERISMO SEGMENTATION TOOL V.2.0	St Jude Medical	2010-09-22	98	0
K101968	SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100	St Jude Medical	2010-09-15	65	0
K101883	6F ENGAGE/ENGAGE TR INTRODUCER	St Jude Medical	2010-09-07	63	0
K101623	INQUIRY AFOCUSII DIAGNOSTIC CATHETER	St Jude Medical	2010-08-13	65	0
K101328	ENSITE VELOCITY SYSTEM	St Jude Medical	2010-07-14	64	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