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 Apr 8, 2011 as substantially equivalent to K020919 (AtriCure, Inc., 2002) and 4 other predicates after an 80-day review. Its family tree reaches back 10 generations to 1995. 5 later devices descend from it.
- Decided
- Apr 8, 2011
- Review
- 80 days
- Class
- Class II
- Product code
- OCL
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K942299 (1995). 59 ancestors in all, the oldest K811390 (1981). 5 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 6 generations between
- 3 generations backK060400 Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate…Medtronic, Inc. · 2006
- 2 generations backK063630 Atricure Ablation SystemAtriCure, Inc. · 2007
- 1 generation backK101174 Atricure Bipolar System Including Isolator Synergy Dual Electrode…AtriCure, Inc. · 2010
- This deviceK110117 Atricure Bipolar SystemAtriCure, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK210477 AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK211311 AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK252056 Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK234151 Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK221358 Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5)…AtriCure, Inc. · 2022
Show all 10 generations
- Root · 10 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 9 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 8 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 7 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 6 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 5 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 4 generations backK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
- 3 generations backK060400 Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate…Medtronic, Inc. · 2006
- 2 generations backK063630 Atricure Ablation SystemAtriCure, Inc. · 2007
- 1 generation backK101174 Atricure Bipolar System Including Isolator Synergy Dual Electrode…AtriCure, Inc. · 2010
- This deviceK110117 Atricure Bipolar SystemAtriCure, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc. · 2021 · cites it directly2descendants
- K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc. · 2021 · cites it directly2descendants
- K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc. · 2025 · 2 generations on0descendants
- K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc. · 2024 · 2 generations on0descendants
- K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −9 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −8 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −7 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −6 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −5 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −4 | K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation System | Medtronic Vascular | 2003 | — |
| −3 | K060400 | Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical… | Medtronic, Inc. | 2006 | — |
| −2 | K063630 | Atricure Ablation System | AtriCure, Inc. | 2007 | — |
| −1 | K101174 | Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model… | AtriCure, Inc. | 2010 | — |
| 0 (this device) | K110117 | Atricure Bipolar System | AtriCure, Inc. | 2011 | — |
| +1 | K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE | AtriCure, Inc. | 2021 | — |
| +1 | K211311 | AtriCure Isolator® Synergy™ Surgical Ablation System | AtriCure, Inc. | 2021 | — |
| +2 | K252056 | Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) | AtriCure, Inc. | 2025 | — |
| +2 | K234151 | Isolator Synergy EnCapture Ablation System (EMH) | AtriCure, Inc. | 2024 | — |
| +1 | K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail®… | AtriCure, Inc. | 2022 | — |
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 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 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? (5)
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…the ablation of cardiac tissue during surgery. Predicate Devices The predicate devices for the AtriCure Bipolar System include the AtriCure Bipolar System (K02091 9), the AtriCure Transpolar System (K052893), the AtriCure Ablation System (K063630), the AtriCure Bipolar System (K043579),… | 2002 |
| * | K052893 | Atricure Transpolar SystemSummary page 1…ry. Predicate Devices The predicate devices for the AtriCure Bipolar System include the AtriCure Bipolar System (K02091 9), the AtriCure Transpolar System (K052893), the AtriCure Ablation System (K063630), the AtriCure Bipolar System (K043579), and the AtriCure Bipolar System inc… | 2005 |
| * | K063630 | Atricure Ablation SystemSummary page 1…ces for the AtriCure Bipolar System include the AtriCure Bipolar System (K02091 9), the AtriCure Transpolar System (K052893), the AtriCure Ablation System (K063630), the AtriCure Bipolar System (K043579), and the AtriCure Bipolar System including Isolator Synergy Dual Electrode Clamps (… | 2007 |
| * | K043579 | Atricure Bipolar SystemSummary page 1…lude the AtriCure Bipolar System (K02091 9), the AtriCure Transpolar System (K052893), the AtriCure Ablation System (K063630), the AtriCure Bipolar System (K043579), and the AtriCure Bipolar System including Isolator Synergy Dual Electrode Clamps (K101 174). Device Description Th… | 2007 |
| * | K101174 | Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…Summary page 1…AtriCure Ablation System (K063630), the AtriCure Bipolar System (K043579), and the AtriCure Bipolar System including Isolator Synergy Dual Electrode Clamps (K101 174). Device Description The AtriCure Bipolar System includes a hand held, single use, bipolar radiofrequency (RF) surg… | 2010 |
What descends from it? (5)
3 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 16 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 59 ancestors have a recall of any class.
- Of its descendants, K210477 (AtriCure, Inc., 2021) has gone furthest, with 2 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. 2011, 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 System is intended for the ablation of caridac tissue during surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110117: Atricure Bipolar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110117
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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