510(k) · Cleared
ClearedAtricure Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AtriCure, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 26, 2007 as substantially equivalent to K020919 (AtriCure, Inc., 2002) and 2 other predicates after a 51-day review. Its family tree reaches back 8 generations to 1995. 7 later devices descend from it.
- Decided
- Jan 26, 2007
- Review
- 51 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K942299 (1995). 41 ancestors in all, the oldest K811390 (1981). 7 later devices descend from it, 2 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 backK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
- 1 generation backK060400 Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate…Medtronic, Inc. · 2006
- This deviceK063630 Atricure Ablation SystemAtriCure, Inc. · 2007
- 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 · 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- 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
- 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
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 | K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation System | Medtronic Vascular | 2003 | — |
| −1 | K060400 | Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical… | Medtronic, Inc. | 2006 | — |
| 0 (this device) | K063630 | Atricure Ablation System | AtriCure, Inc. | 2007 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 7 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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, RHP1 | 2002 |
| * | K052893 | Atricure Transpolar SystemSummary page 1…gy. Predicate Devices The predicate devices for the AtriCure Ablation System are the AtriCure Bipolar System (KO20919), the AtriCure Transpolar~m System (K052893), and the Medtronic Cardloiablate Surgical Ablation System (K(060400) Device Description The AtriCure Ablation Sy… | 2005 |
| * | K060400 | Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation…Summary page 1…System are the AtriCure Bipolar System (KO20919), the AtriCure Transpolar~m System (K052893), and the Medtronic Cardloiablate Surgical Ablation System (K(060400) Device Description The AtriCure Ablation System includes a hand held, single use, bipolar radiofrequency (RF) su… | 2006 |
What descends from it? (7)
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 12 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 41 ancestors have a recall of any class.
- Of its descendants, K101174 (AtriCure, Inc., 2010) has gone furthest, with 6 descendants of its own.
- 8 other devices also cite its predicate K020919.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The AtriCure Ablation System is intended to ablate soft tissues during general surgery using radiofrequency energy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063630 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063630: Atricure 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/K063630
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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