510(k) · Cleared
ClearedCardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation Device, Model 60831; Cardioblat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 28, 2006 as substantially equivalent to K031247 (Medtronic Vascular, 2003) after a 13-day review. Its family tree reaches back 7 generations to 1995. 14 later devices descend from it.
- Decided
- Feb 28, 2006
- Review
- 13 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K942299 (1995). 39 ancestors in all, the oldest K811390 (1981). 14 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 6 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 5 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 4 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 3 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 2 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 1 generation backK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
- This deviceK060400 Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate…Medtronic, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK063630 Atricure Ablation SystemAtriCure, Inc. · 2007
- Descendant · 2 generations on · 6 of its ownK101174 Atricure Bipolar System Including Isolator Synergy Dual Electrode…AtriCure, Inc. · 2010
- Descendant · 2 generations on · 5 of its ownK110117 Atricure Bipolar SystemAtriCure, Inc. · 2011
- Descendant · 3 generations on · 2 of its ownK210477 AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK211311 AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc. · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K063630Atricure Ablation SystemAtriCure, Inc. · 2007 · cites it directly7descendants
- K101174Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…AtriCure, Inc. · 2010 · 2 generations on6descendants
- K110117Atricure Bipolar SystemAtriCure, Inc. · 2011 · 2 generations on5descendants
- K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc. · 2021 · 3 generations on2descendants
- K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc. · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −6 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −5 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −4 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −3 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −2 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −1 | K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation System | Medtronic Vascular | 2003 | — |
| 0 (this device) | K060400 | Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical… | Medtronic, Inc. | 2006 | — |
| +1 | K063630 | Atricure Ablation System | AtriCure, Inc. | 2007 | — |
| +2 | K101174 | Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model… | AtriCure, Inc. | 2010 | — |
| +2 | K110117 | Atricure Bipolar System | AtriCure, Inc. | 2011 | — |
| +3 | K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE | AtriCure, Inc. | 2021 | — |
| +3 | K211311 | AtriCure Isolator® Synergy™ Surgical Ablation System | AtriCure, Inc. | 2021 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation SystemSummary page 1…878.4400 Product Code: GEI Predicate Device: Cardioblate® Bipolar Radiofrequency Ablation System 510(k) No. K031247, Reg. No. 878.4400; Product Code: GEl Predicate Device Intended Use: The Medtronic Cardioblate®… | 2003 |
What descends from it? (14)
See all 145 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 11 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 39 ancestors have a recall of any class.
- Of its descendants, K063630 (AtriCure, Inc., 2007) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K031247.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Medtronic Cardioblate® System is intended to ablate soft tissue during general surgery using radiofrequency energy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060400 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060400: Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation Device, Model 60831; Cardioblat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060400
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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