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

AtriCure, Inc. — Predicate Candidate Screening

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

36 daysmedian FDA review time

216 days90th percentile

59clearances 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
K250371	cryoICE cryoXT cryoablation probe (cryoXT)	AtriCure, Inc.	2025-04-10	59	0
K243860	AtriClip PRO-Mini LAA Exclusion System (PROM)	AtriCure, Inc.	2025-01-15	30	0
K243157	AtriCure cryoICE BOX (ACM)	AtriCure, Inc.	2024-10-29	29	0
K234151	Isolator Synergy EnCapture Ablation System (EMH)	AtriCure, Inc.	2024-08-27	242	0
K234125	AtriClip FLEX-Mini LAA Exclusion System (ACHM)	AtriCure, Inc.	2024-07-29	214	0
K233959	EPi-Ease Epicardial Access Device (EAS)	AtriCure, Inc.	2024-02-13	60	0
K233407	AtriClip LAA Exclusion System with preloaded Gillinov-Cosgro	AtriCure, Inc.	2023-11-02	28	0
K233170	cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cry	AtriCure, Inc.	2023-10-26	29	0
K221358	Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1	AtriCure, Inc.	2022-12-30	233	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
K210293	AtriClip LAA Exclusion System	AtriCure, Inc.	2021-03-03	29	0
K200697	AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryo	AtriCure, Inc.	2020-12-23	281	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
K191413	AtriClip LAA Exclusion System with preloaded Gillinov-Cosgro	AtriCure, Inc.	2019-08-21	85	0
K190587	Coolrail Linear Pen	AtriCure, Inc.	2019-07-24	139	0
K190151	COBRA Fusion Ablation System	AtriCure, Inc.	2019-02-25	26	0
K183065	Coolrail Linear Pen	AtriCure, Inc.	2018-12-04	29	0
K182565	AtriCure cryoICE cryoSPHERE cryoablation probe	AtriCure, Inc.	2018-11-09	52	0
K181474	ArtiClip LAA Exclusion System	AtriCure, Inc.	2018-06-28	24	0
K180138	AtriCure cryoICE cryo-ablation probe (CRYO2)	AtriCure, Inc.	2018-02-15	29	0
K180137	AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoI	AtriCure, Inc.	2018-02-15	29	0
K180010	AtriClip FLEX-V	AtriCure, Inc.	2018-01-31	29	0
K173031	AtriClip LAA Exclusion System with Preloaded PRO·V Clip	AtriCure, Inc.	2017-10-25	27	0
K172742	AtriClip LAA Exclusion System with preloaded Gillinov-Cosgro	AtriCure, Inc.	2017-10-11	29	0
K163261	AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices w	AtriCure, Inc.	2017-05-19	179	0
K163408	Isolator Multifunctional Linear Pen	AtriCure, Inc.	2017-01-03	29	0
K152337	cryoFORM cryoICE cryoablation probe	AtriCure, Inc.	2016-03-22	216	0
K160454	AtriClip LAA Exclusion System with preloaded Gillinov-Cosgro	AtriCure, Inc.	2016-03-18	29	0
K153500	AtriClip LAA Exclusion System with preloaded Gillinov-Cosgro	AtriCure, Inc.	2016-01-27	51	0
K150996	AtriClip LAA Exclusion System with preloaded Gillinov-Cosgro	AtriCure, Inc.	2015-06-17	63	0
K142203	Atricure Cryo Module System; cryoICE cryoablation probe	AtriCure, Inc.	2014-11-25	106	0
K142441	cryoICE croablation probe	AtriCure, Inc.	2014-10-29	57	0
K142120	ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGRO	AtriCure, Inc.	2014-08-28	24	0
K140058	ATRICURE CRYO MODULE SYSTEM	AtriCure, Inc.	2014-01-24	14	2
K131107	ATRICLIP GILLINOV-COSGROVE LAA CLIP	AtriCure, Inc.	2013-05-14	25	0
K130521	ISOLATOR LINEAR PEN	AtriCure, Inc.	2013-04-05	36	0
K122611	COOLRAIL LINEAR PEN MODEL MCRI	AtriCure, Inc.	2012-09-26	30	0
K122276	ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGRO	AtriCure, Inc.	2012-08-29	30	0
K121507	ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)	AtriCure, Inc.	2012-06-06	16	0
K112072	ATRICURE CRYO MODULE SYSTEM	AtriCure, Inc.	2011-08-03	14	0
K111020	ATRICURE DISSECTOR	AtriCure, Inc.	2011-06-09	58	0
K111042	ATRICURE CRYO MODULE	AtriCure, Inc.	2011-05-26	41	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
K093679	ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGRO	AtriCure, Inc.	2010-06-10	195	0
K082074	ATRICURE CRYO1 CRYO-ABLATION PROBE	AtriCure, Inc.	2009-03-02	222	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