510(k) · Cleared
ClearedAtriCure Isolator® Synergy™ Surgical Ablation 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 May 28, 2021 as substantially equivalent to K110117 (AtriCure, Inc., 2011) after a 28-day review. Its family tree reaches back 11 generations to 1995. 2 later devices descend from it.
- Decided
- May 28, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- OCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K942299 (1995). 60 ancestors in all, the oldest K811390 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 7 generations between
- 3 generations backK063630 Atricure Ablation SystemAtriCure, Inc. · 2007
- 2 generations backK101174 Atricure Bipolar System Including Isolator Synergy Dual Electrode…AtriCure, Inc. · 2010
- 1 generation backK110117 Atricure Bipolar SystemAtriCure, Inc. · 2011
- This deviceK211311 AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc. · 2021
- Descendant · cites it directly · 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 11 generations
- Root · 11 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 10 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 9 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 8 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 7 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 6 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 5 generations backK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
- 4 generations backK060400 Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate…Medtronic, Inc. · 2006
- 3 generations backK063630 Atricure Ablation SystemAtriCure, Inc. · 2007
- 2 generations backK101174 Atricure Bipolar System Including Isolator Synergy Dual Electrode…AtriCure, Inc. · 2010
- 1 generation backK110117 Atricure Bipolar SystemAtriCure, Inc. · 2011
- This deviceK211311 AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −10 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −9 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −8 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −7 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −6 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −5 | K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation System | Medtronic Vascular | 2003 | — |
| −4 | K060400 | Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical… | Medtronic, Inc. | 2006 | — |
| −3 | K063630 | Atricure Ablation System | AtriCure, Inc. | 2007 | — |
| −2 | K101174 | Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model… | AtriCure, Inc. | 2010 | — |
| −1 | K110117 | Atricure Bipolar System | AtriCure, Inc. | 2011 | — |
| 0 (this device) | K211311 | AtriCure Isolator® Synergy™ Surgical Ablation System | AtriCure, Inc. | 2021 | — |
| +1 | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 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? (1)
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 |
|---|---|---|---|
| * | K110117 | Atricure Bipolar SystemSummary page 4…Product Code: OCL Classification Paneli: Card ovascular Predicate Device: AtriCure Bipolar System (EMR2, EML2) (K110117, April 8, 2011) III. Device Description The AtriCure Isolator Synergy Surgical Ablation System is comprised of the Ablatio… | 2011 |
What descends from it? (2)
2 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 26 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 60 ancestors have a recall of any class.
- Of its descendants, K234151 (AtriCure, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K110117.
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. 2021, 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 Isolator Synergy Surgical Ablation System is intended to ablate cardiac tissue during surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211311 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211311: AtriCure Isolator® Synergy™ Surgical Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211311
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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