# AtriCure, Inc.

- Location (FDA's records): Mason, OH
- FDA decisions: 62 (2001–2026): 60 510(k) clearances and 2 original PMA approvals
- Product codes: OCL (20), FZP (11), GEH (8), PZX (7), GXH (7), GEI (4), FTD (2), OCM (2), DYB (1)
- 510(k) review time since 2016: median 30 days, against 66 for FDA's reviews in the same codes and years (9 of 16 faster)
- Predicates its devices cite: 122 (78 its own); citations of its devices by later devices: 97 (78 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Vascular: 4 (https://510kreport.com/company/medtronic-vascular)
- Heartport, Inc.: 3 (https://510kreport.com/company/heartport)
- Symbiosis Corp.: 2 (https://510kreport.com/company/symbiosis)
- Everest Medical Corp.: 2 (https://510kreport.com/company/everest-medical)
- Cryogen, Inc.: 2 (https://510kreport.com/company/cryogen)
- Galil Medical, Ltd.: 2 (https://510kreport.com/company/galil-medical)
- Frigitronics of Connecticut, Inc.: 2 (https://510kreport.com/company/frigitronics-of-connecticut)
- Cryocath Technologies, Inc.: 2 (https://510kreport.com/company/cryocath-technologies)

## Firms that cite its devices most
- Medtronic Vascular: 3 (https://510kreport.com/company/medtronic-vascular)
- Epicor Medical, Inc.: 2 (https://510kreport.com/company/epicor-medical)
- Cryocath Technologies, Inc.: 2 (https://510kreport.com/company/cryocath-technologies)
- Engineered Medical Solutions Co., LLC: 1 (https://510kreport.com/company/engineered-medical-solutions)
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)
- Revelle Aesthetics, Inc.: 1 (https://510kreport.com/company/revelle-aesthetics)
- Trod Medical SA: 1 (https://510kreport.com/company/trod-medical)
- Medinice S.A.: 1 (https://510kreport.com/company/medinice)

## Its most-cited devices
- K020919: Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 (2002), cited by 9
- K122276: Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip (2012), cited by 5
- K093679: Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove Section Guide  Model Various LAA0 (2010), cited by 5
- K011722: Atricure Bipolar Coagulation System (2001), cited by 4
- K112072: Atricure Cryo Module System (2011), cited by 4
- K142203: Atricure Cryo Module System; cryoICE cryoablation probe (2014), cited by 3

## Recent decisions
- K263319: ACHM30 AtriClip FLEX-Mini LAA Exclusion System (Oct 21, 2026)
- K252056: Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) (Jul 24, 2025)
- K250371: cryoICE cryoXT cryoablation probe (cryoXT) (Apr 10, 2025)
- K243860: AtriClip PRO-Mini LAA Exclusion System (PROM) (Jan 15, 2025)
- K243157: AtriCure cryoICE BOX (ACM) (Oct 29, 2024)
- K234151: Isolator Synergy EnCapture Ablation System (EMH) (Aug 27, 2024)
- K234125: AtriClip FLEX-Mini LAA Exclusion System (ACHM) (Jul 29, 2024)
- K233959: EPi-Ease Epicardial Access Device (EAS) (Feb 13, 2024)

Source page: https://510kreport.com/company/atricure