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

DRF — Predicate Candidate Screening

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

114 daysmedian FDA review time

378 days90th percentile

185clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252794	Vision-MR™ Diagnostic Catheter	Imricor Medical Systems, Inc.	2026-01-08	128	0
K250590	MAGiC Sweep™ EP Mapping Catheter	Stereotaxis, Inc.	2025-07-23	146	0
K250310	VIKING™ Fixed Curve Diagnostic Catheter	Boston Scientific Corporation	2025-06-27	144	0
K240366	EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic	Boston Scientific Corporation	2024-11-01	269	0
K233900	Nordica PV Cryo Mapping Catheter	Synaptic Medical Corporation	2024-09-06	270	0
K233397	Cosine-10TM Diagnostic Catheter	Medtronic, Inc.	2023-12-02	60	0
K233207	Polaris X™ Unidirectional Steerable Diagnostic Catheter	Boston Scientific Corporation	2023-10-27	29	0
K232651	BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter	Boston Scientific Corporation	2023-09-29	29	0
K230503	Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable	Boston Scientific	2023-04-25	60	0
K210313	EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for	Shanghai Microport EP Medtech Co., Ltd.	2022-12-30	695	0
K220796	IntellaMap Orion High Resolution Mapping Catheter	Boston Scientific Corporation	2022-06-10	84	0
K203793	RithmID-SD Steerable Diagnostic Electrophysiology Catheter	Synaptic Medical Corporation	2022-02-14	413	0
K211327	Khelix Steerable Electrophysiology Catheters, Khelix Loop Fi	CathRx, Ltd.	2022-02-10	283	0
K211219	LASSOSTAR NAV Circular Mapping Catheter	Biosense Webster, Inc.	2022-01-26	278	0
K212593	ViaCath, AcQRate Dx Steerable Catheter	Biotronick, Inc.	2021-10-15	60	0
K211494	Polaris X Unidirectional Steerable Diagnostic Catheter	Boston Scientific Corporation	2021-09-14	124	0
K211375	Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter	Boston Scientific Corporation	2021-09-10	129	0
K201445	MultiCath, AcQRate Dx Fixed Curve Catheter	Biotronik, Inc.	2021-09-02	458	0
K203261	Reprocessed Inquiry Steerable Diagnostic EP Catheter	Innovative Health, LLC	2021-03-05	120	0
K193632	LassoStar Circular Mapping Catheter	Biosense Webster, Inc.	2020-06-30	186	0
K191880	Reprocessed Achieve Advance Mapping Diagnostic Electrophysio	Innovative Health, LLC	2019-12-11	149	0
K192360	IntellaMap Orion High Resolution Mapping Catheter	Boston Scientific Corporation	2019-10-25	56	0
K192037	Advisor VL Circular Mapping Catheter, Sensor Enabled	ABBOTT MEDICAL	2019-09-17	49	0
K183547	Marinr Steerable Intracardiac Electrode Catheter, StableMapr	Medtronic	2019-07-30	222	0
K190132	Torqr Intracardiac Electrode Catheter, Soloist Intracardiac	Medtronic	2019-07-30	183	0
K190980	Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter	Innovative Health, LLC	2019-07-01	77	0
K183649	Diagnostic Fixed Electrophysiology Catheter, Diagnostic Elec	Baylis Medical Company, Inc.	2019-06-07	163	0
K183632	Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnost	Baylis Medical Company, Inc.	2019-06-07	163	0
K182386	Reprocessed Supreme Diagnostic Electrophysiology Catheter	Innovative Health, LLC	2019-04-23	231	0
K171277	Reprocessed Inquiry Steerable Diagnostic EP Catheter	Innovative Health, LLC	2017-10-23	175	0
K160335	Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 5	St Jude Medical	2016-12-13	309	0
K161769	Reprocessed Supreme Diagnostic Electrophysiology Catheters	Innovative Health, LLC	2016-12-06	161	0
K162892	Achieve Advance Mapping Catheter	Medtronic, Inc.	2016-11-15	29	0
K151139	EasyMap MAP Catheter	Medfact Engineering GmbH	2016-10-18	538	0
K153139	Achieve ST Mapping Catheter, Catheter Connecting Cable	Medtronic, Inc.	2016-05-06	189	0
K160390	Map-it Diagnostic Mapping Catheters	Access Point Technologies Ep, Inc.	2016-04-11	60	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
K143481	IntellaMap Orion High Resolution Mapping Catheter	Rhythmia Medical, Inc.	2015-01-08	31	0
K133028	RITHM ID ELECTROPHYSIOLOGY CATHETER	Synaptic Medical Limited	2014-03-04	159	0
K130602	LASSO NAV DUO LOOP CATHETER	Biosense Webster, Inc.	2013-08-14	160	1
K122461	RHYTHMIA MAPPING CATHETER	Rhythmia Medical, Inc.	2013-04-18	248	1
K120544	RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN	St Jude Medical	2012-03-19	25	0
K113213	LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER	Biosense Webster, Inc.	2011-12-05	34	1
K101991	WEBSTER DUO-DECAPOLAR CATHETER	Biosense Webster, Inc.	2011-05-02	292	0
K102588	ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE	Medtronic Ablation Frontiers, LLC	2011-03-18	190	1
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
K101623	INQUIRY AFOCUSII DIAGNOSTIC CATHETER	St Jude Medical	2010-08-13	65	0
K101345	WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CAT	Biosense Webster, Inc.	2010-06-22	40	1

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