510(k) · Cleared
ClearedAtricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2, OSL2, EMR2, EML2
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 Nov 12, 2010 as substantially equivalent to K043579 (AtriCure, Inc., 2007) and 1 other predicate after a 199-day review. Its family tree reaches back 9 generations to 1995. 6 later devices descend from it.
- Decided
- Nov 12, 2010
- Review
- 199 days
- Class
- Class II
- Product code
- OCL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K942299 (1995). 58 ancestors in all, the oldest K811390 (1981). 6 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 5 generations between
- 3 generations backK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
- 2 generations backK060400 Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate…Medtronic, Inc. · 2006
- 1 generation backK063630 Atricure Ablation SystemAtriCure, Inc. · 2007
- This deviceK101174 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 · 2 of its ownK210477 AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK211311 AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK252056 Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK234151 Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 8 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 7 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 6 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 5 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 4 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 3 generations backK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
- 2 generations backK060400 Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate…Medtronic, Inc. · 2006
- 1 generation backK063630 Atricure Ablation SystemAtriCure, Inc. · 2007
- This deviceK101174 Atricure Bipolar System Including Isolator Synergy Dual Electrode…AtriCure, Inc. · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K110117Atricure Bipolar SystemAtriCure, Inc. · 2011 · cites it directly5descendants
- K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc. · 2021 · 2 generations on2descendants
- K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc. · 2021 · 2 generations on2descendants
- K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc. · 2025 · 3 generations on0descendants
- K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −8 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −7 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −6 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −5 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −4 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −3 | K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation System | Medtronic Vascular | 2003 | — |
| −2 | K060400 | Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical… | Medtronic, Inc. | 2006 | — |
| −1 | K063630 | Atricure Ablation System | AtriCure, Inc. | 2007 | — |
| 0 (this device) | K101174 | Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model… | AtriCure, Inc. | 2010 | — |
| +1 | K110117 | Atricure Bipolar System | AtriCure, Inc. | 2011 | — |
| +2 | K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE | AtriCure, Inc. | 2021 | — |
| +2 | K211311 | AtriCure Isolator® Synergy™ Surgical Ablation System | AtriCure, Inc. | 2021 | — |
| +3 | K252056 | Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) | AtriCure, Inc. | 2025 | — |
| +3 | K234151 | Isolator Synergy EnCapture Ablation System (EMH) | AtriCure, Inc. | 2024 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K043579 | Atricure Bipolar SystemSummary page 1…ar System is intended for the ablation of cardiac tissue during surgery. Predicate Devices AtriCure Bipolar System (including Isolator Single Electrode clamps) K043579 Manufactured by AtriCure, Inc. AtriCure Bipolar System (including Isolator Synergy Dual Electrode K063630 cla… | 2007 |
| * | K063630 | Atricure Ablation SystemSummary page 1…Isolator Single Electrode clamps) K043579 Manufactured by AtriCure, Inc. AtriCure Bipolar System (including Isolator Synergy Dual Electrode K063630 clamps) Manufactured by AtriCure, Inc. Device Description The AtriCure Bipolar System includes hand held, single use, du… | 2007 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110117 | Atricure Bipolar System | 2011 | 5 |
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 15 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 58 ancestors have a recall of any class.
- Of its descendants, K110117 (AtriCure, Inc., 2011) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K043579.
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. 2010, 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 including Isolator Synergy Dual Electrode Clamps is intended for the ablation of cardiac tissue during surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101174: Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2, OSL2, EMR2, EML2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101174
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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