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

OCL — Predicate Candidate Screening

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

81 daysmedian FDA review time

199 days90th percentile

54clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252056	Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OS	AtriCure, Inc.	2025-07-24	23	0
K234151	Isolator Synergy EnCapture Ablation System (EMH)	AtriCure, Inc.	2024-08-27	242	0
K221358	Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1	AtriCure, Inc.	2022-12-30	233	0
K223508	Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardiob	Medtronic, Inc.	2022-12-22	30	0
K210477	AtriCure Isolator Encompass Ablation System, GLIDEPATH Magne	AtriCure, Inc.	2021-07-26	157	0
K211311	AtriCure Isolator® Synergy™ Surgical Ablation System	AtriCure, Inc.	2021-05-28	28	0
K200514	Cardioblate Gemini-s Surgical Ablation Device	Medtronic	2020-06-03	93	0
K193162	EPi-Sense Guided Coagulation System with VisiTrax	AtriCure, Inc.	2019-12-13	28	0
K192125	Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Line	AtriCure, Inc.	2019-11-04	90	0
K191526	Cardioblate CryoFlex Surgical Ablation System	Medtronic, Inc.	2019-10-01	113	0
K190587	Coolrail Linear Pen	AtriCure, Inc.	2019-07-24	139	0
K190623	Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen	Medtronic	2019-05-30	80	0
K190151	COBRA Fusion Ablation System	AtriCure, Inc.	2019-02-25	26	0
K182610	Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Sur	Medtronic	2018-12-19	89	0
K183065	Coolrail Linear Pen	AtriCure, Inc.	2018-12-04	29	0
K163408	Isolator Multifunctional Linear Pen	AtriCure, Inc.	2017-01-03	29	0
K142084	EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX	Ncontact Surgical, Inc.	2014-10-28	89	0
K130521	ISOLATOR LINEAR PEN	AtriCure, Inc.	2013-04-05	36	0
K123733	CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM	Medtronic, Inc.	2013-04-01	117	0
K120857	EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX	Ncontact Surgical, Inc.	2012-11-13	237	0
K121878	CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES	Medtronic, Inc.	2012-11-02	127	0
K122611	COOLRAIL LINEAR PEN MODEL MCRI	AtriCure, Inc.	2012-09-26	30	0
K121767	CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE	Medtronic, Inc.	2012-07-13	28	0
K121451	CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SE	Medtronic, Inc.	2012-06-14	29	0
K113475	ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM	Endoscopic Technologies, Inc. D/B/A Estech	2012-03-20	119	0
K110913	ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY	Endoscopic Technologies, Inc. D/B/A Estech	2011-09-23	175	0
K110117	ATRICURE BIPOLAR SYSTEM	AtriCure, Inc.	2011-04-08	80	0
K101174	ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELEC	AtriCure, Inc.	2010-11-12	199	0
K100501	MULTIFUNCTIONAL LINEAR PEN	AtriCure, Inc.	2010-06-18	116	0
K090721	CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENS	Medtronic	2009-06-16	90	0
K090202	NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-	Ncontact Surgical, Inc.	2009-02-17	21	0
K082203	NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;C	Ncontact Surgical, Inc.	2008-12-30	147	0
K082279	EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2	St Jude Medical	2008-09-16	36	0
K080292	EPICOR ABLATION SYSTEM	St Jude Medical	2008-07-25	172	2
K080509	CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP	Medtronic, Inc.	2008-05-05	70	0
K073605	ATRICURE COOLRAIL LINEAR PEN	AtriCure, Inc.	2008-03-11	81	0
K071819	NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-	Ncontact Surgical, Inc.	2007-07-26	23	0
K043579	ATRICURE BIPOLAR SYSTEM	AtriCure, Inc.	2007-07-05	919	0
K070288	CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL,	Medtronic Vascular	2007-06-18	139	0
K063012	NCONTACT COAGULATION SYSTEM KIT, MODEL CSK	Ncontact Surgical, Inc.	2006-12-01	60	0
K062140	SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICA	Cryocath Technologies, Inc.	2006-08-24	28	0
K061593	ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1,	AtriCure, Inc.	2006-07-12	34	1
K060715	MODIFICATION TO: CARDIMA ABLATION SYSTEM	Cardima, Inc.	2006-05-15	59	2
K053436	SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROS	Cryocath Technologies, Inc.	2006-01-13	35	1
K050459	ATRICURE ISOLATOR TRANSPOLAR PEN	AtriCure, Inc.	2005-06-13	110	1
K041890	CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 125	Cryocor, Inc.	2004-09-22	72	0
K040690	SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AN	Cryocath Technologies, Inc.	2004-04-29	44	0
K022008	CARDIMA ABLATION SYSTEM	Cardima, Inc.	2003-01-29	224	2
K021010	MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE	Endocare, Inc.	2002-06-06	69	0
K013392	CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE	Medtronic Vascular	2002-01-25	102	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