510(k) · Cleared
ClearedAtricure Bipolar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AtriCure, Inc. · OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Cleared on Jul 5, 2007 as substantially equivalent to K020919 (AtriCure, Inc., 2002) and 5 other predicates after a 919-day review. Its family tree reaches back 8 generations to 1995. 18 later devices descend from it.
- Decided
- Jul 5, 2007
- Review
- 919 days
- Class
- Class II
- Product code
- OCL
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K942299 (1995). 53 ancestors in all, the oldest K811390 (1981). 18 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 7 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 6 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 5 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 4 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 3 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 2 generations backK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
- 1 generation backK040641 Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8…Epicor Medical, Inc. · 2004
- This deviceK043579 Atricure Bipolar SystemAtriCure, Inc. · 2007
- Descendant · cites it directly · 10 of its ownK080509 Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP…Medtronic, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK101174 Atricure Bipolar System Including Isolator Synergy Dual Electrode…AtriCure, Inc. · 2010
- Descendant · cites it directly · 5 of its ownK110117 Atricure Bipolar SystemAtriCure, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK093203 Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models…Medtronic, Inc. · 2010
- Descendant · 2 generations on · 2 of its ownK210477 AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc. · 2021
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device…Medtronic, Inc. · 2008 · cites it directly10descendants
- K101174Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…AtriCure, Inc. · 2010 · cites it directly6descendants
- K110117Atricure Bipolar SystemAtriCure, Inc. · 2011 · cites it directly5descendants
- K093203Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841Medtronic, Inc. · 2010 · 2 generations on3descendants
- K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc. · 2021 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −7 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −6 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −5 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −4 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −3 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −2 | K022894 | Epicor Medical Ablation System | Epicor Medical, Inc. | 2004 | — |
| −1 | K040641 | Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9… | Epicor Medical, Inc. | 2004 | — |
| 0 (this device) | K043579 | Atricure Bipolar System | AtriCure, Inc. | 2007 | — |
| +1 | K080509 | Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation… | Medtronic, Inc. | 2008 | — |
| +1 | K101174 | Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model… | AtriCure, Inc. | 2010 | — |
| +1 | K110117 | Atricure Bipolar System | AtriCure, Inc. | 2011 | — |
| +2 | K093203 | Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831… | Medtronic, Inc. | 2010 | — |
| +2 | K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE | AtriCure, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 7 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OCL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OCL device
- #1 K252056 Isolator® Synergy™ EnCompass Clamp and Guide…score 13.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1Summary page 1…is intended for the ablation of cardiac tissue during surgery. Predicate Devices The predicate devices for the AtriCure Bipolar System are the Atricure Bipolar System (K020919), the Medtronic Cardioblate Pen (K013392), the Boston Scientific Cobra Cardiac Surgical Probe (K013873), the CryoCath SurgiFrost… | 2002 |
| * | K013392 | Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation…Summary page 1…tissue during surgery. Predicate Devices The predicate devices for the AtriCure Bipolar System are the Atricure Bipolar System (K020919), the Medtronic Cardioblate Pen (K013392), the Boston Scientific Cobra Cardiac Surgical Probe (K013873), the CryoCath SurgiFrost Cryosurgical Device with FrostByte Clamp… | 2002 |
| * | K013873 | Cobra Cardiac Electrosurgical SystemSummary page 1…s for the AtriCure Bipolar System are the Atricure Bipolar System (K020919), the Medtronic Cardioblate Pen (K013392), the Boston Scientific Cobra Cardiac Surgical Probe (K013873), the CryoCath SurgiFrost Cryosurgical Device with FrostByte Clamp (K040690), the AFx Microwave Ablation System (K003978) and the… | 2002 |
| * | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleSummary page 1…the Medtronic Cardioblate Pen (K013392), the Boston Scientific Cobra Cardiac Surgical Probe (K013873), the CryoCath SurgiFrost Cryosurgical Device with FrostByte Clamp (K040690), the AFx Microwave Ablation System (K003978) and the Epicor Medical Ultracinch Tissue Ablation Device (K040641). Device Descript… | 2004 |
| * | K003978 | Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N…Summary page 1…Boston Scientific Cobra Cardiac Surgical Probe (K013873), the CryoCath SurgiFrost Cryosurgical Device with FrostByte Clamp (K040690), the AFx Microwave Ablation System (K003978) and the Epicor Medical Ultracinch Tissue Ablation Device (K040641). Device Description The Atricure Bipolar System is comprised… | 2001 |
| * | K040641 | Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Summary page 1…Cath SurgiFrost Cryosurgical Device with FrostByte Clamp (K040690), the AFx Microwave Ablation System (K003978) and the Epicor Medical Ultracinch Tissue Ablation Device (K040641). Device Description The Atricure Bipolar System is comprised of a bipolar clamping hand-piece with integral cable (IsolatorTM),… | 2004 |
What descends from it? (18)
See all 183 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 53 ancestors have a recall of any class.
- Of its descendants, K080509 (Medtronic, Inc., 2008) has gone furthest, with 10 descendants of its own.
- 8 other devices also cite its predicate K020919.
How does its category compare?
All OCL devicesOCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · OCL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCL
85in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCL
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCL
46in 2025
MAUDE reports naming product code OCL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 139 | 0 | 0 |
| 2008 | 5 | 81 | 1 | 0 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 2 | — | 2 | 23 |
| 2011 | 2 | — | 0 | 21 |
| 2012 | 6 | 75 | 0 | 21 |
| 2013 | 2 | — | 1 | 13 |
| 2014 | 1 | — | 0 | 15 |
| 2015 | 0 | — | 0 | 31 |
| 2016 | 0 | — | 1 | 76 |
| 2017 | 1 | — | 0 | 55 |
| 2018 | 2 | — | 0 | 61 |
| 2019 | 6 | 85 | 4 | 49 |
| 2020 | 1 | — | 4 | 37 |
| 2021 | 2 | — | 1 | 63 |
| 2022 | 2 | — | 0 | 59 |
| 2023 | 0 | — | 0 | 99 |
| 2024 | 1 | — | 0 | 59 |
| 2025 | 1 | — | 0 | 46 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AtriCure Bipolar (Transpolar)System is intended for the ablation of cardiac tissue during surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043579 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043579: Atricure Bipolar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043579
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026