AtriCure, Inc.: FDA clearances and approvals
AtriCure, Inc. has 59 FDA 510(k) clearances (first 2001, latest 2025), plus 2 PMA decisions, across 9 product codes in 3 review panels. Median 510(k) review time: 36 days. Since 2017 its median was 29 days, against 97 days for all cleared 510(k)s in the same product codes. openFDA lists 13 product recalls by a recalling firm named AtriCure, Inc. It is the industry lead sponsor of 27 device clinical trials on ClinicalTrials.gov. It files with the SEC as AtriCure, Inc. (ATRC).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 30 |
| 2013 | 2 | 30 |
| 2014 | 4 | 40 |
| 2015 | 1 | 63 |
| 2016 | 3 | 51 |
| 2017 | 4 | 29 |
| 2018 | 6 | 29 |
| 2019 | 5 | 85 |
| 2020 | 1 | 281 |
| 2021 | 3 | 29 |
| 2022 | 1 | 233 |
| 2023 | 2 | 28 |
| 2024 | 4 | 137 |
| 2025 | 3 | 30 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, AtriCure, Inc.'s cleared 510(k)s took a median 29 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 97 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | 20 | 20 |
| FZP | Clip, Implantable | 11 | 11 |
| GEH | Unit, Cryosurgical, Accessories | 8 | 8 |
| GXH | Device, Surgical, Cryogenic | 7 | 7 |
| PZX | Left Atrial Appendage Clip, Implantable | 6 | 6 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| FTD | Lamp, Surgical | 2 | 2 |
| OCM | Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation | 2 | 0 |
| DYB | Introducer, Catheter | 1 | 1 |
Review panels
- Cardiovascular (29)
- General and Plastic Surgery (25)
- Neurology (7)
Most recent AtriCure, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252056 | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100) | OCL | 2025-07-24 | 23 |
| K250371 | cryoICE cryoXT cryoablation probe (cryoXT) | GXH | 2025-04-10 | 59 |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) | PZX | 2025-01-15 | 30 |
| K243157 | AtriCure cryoICE BOX (ACM) | GXH | 2024-10-29 | 29 |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH) | OCL | 2024-08-27 | 242 |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | PZX | 2024-07-29 | 214 |
| K233959 | EPi-Ease Epicardial Access Device (EAS) | DYB | 2024-02-13 | 60 |
| K233407 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV) | PZX | 2023-11-02 | 28 |
| K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) | GXH | 2023-10-26 | 29 |
| K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1) | OCL | 2022-12-30 | 233 |
49 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P200002 | PMA | EPi-Sense Guided Coagulation System | 2021-04-28 |
| P100046 | PMA | ATRICURE SYNERGY ABLATION SYSTEM | 2011-12-14 |
Recalls
13 product recalls in 9 recall events; 2 initiated in the last five years. Most recent: 2023-11-28.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
AtriCure, Inc. is the industry lead sponsor of 27 device studies on ClinicalTrials.gov (9 active or recruiting). Most recent:
- NCT06989775: BoxX-NoAF Clinical Trial (Recruiting, started 2025-10-24)
- NCT06908538: Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain (Recruiting, started 2025-04-01)
- NCT05478304: Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial (Active not recruiting, started 2023-01-25)
- NCT05280093: HEAL-IST IDE Trial (Active not recruiting, started 2022-05-31)
- NCT05089877: FREEZE-AFIB Post-Market Study (Completed, started 2022-04-29)
SEC filings
AtriCure, Inc. (ATRC): EDGAR filings, CIK 1323885. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does AtriCure, Inc. have?
AtriCure, Inc. has 59 FDA 510(k) clearances (first 2001, latest 2025), plus 2 PMA decisions, across 9 product codes in 3 review panels.
How long does FDA take to clear AtriCure, Inc.'s 510(k)s?
The median time from FDA receipt to decision across AtriCure, Inc.'s cleared 510(k)s is 36 days. Since 2017: 29 days, versus 97 days for all cleared 510(k)s in the same product codes.
What devices does AtriCure, Inc. make?
Its most frequent FDA product codes are OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue, 20); FZP (Clip, Implantable, 11); GEH (Unit, Cryosurgical, Accessories, 8).
Has AtriCure, Inc. had device recalls?
openFDA lists 13 product recalls in 9 recall events by a recalling firm whose name matches AtriCure, Inc; the most recent began 2023-11-28. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 59 AtriCure, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OCL, AtriCure, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.