510(k) · Cleared
ClearedCardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841
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 26, 2010 as substantially equivalent to K080509 (Medtronic, Inc., 2008) after a 136-day review. Its family tree reaches back 10 generations to 1995. 3 later devices descend from it.
- Decided
- Feb 26, 2010
- Review
- 136 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K942299 (1995). 55 ancestors in all, the oldest K811390 (1981). 3 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 6 generations between
- 3 generations backK040641 Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8…Epicor Medical, Inc. · 2004
- 2 generations backK043579 Atricure Bipolar SystemAtriCure, Inc. · 2007
- 1 generation backK080509 Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP…Medtronic, Inc. · 2008
- This deviceK093203 Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models…Medtronic, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK182610 Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical…Medtronic · 2018
- Descendant · 2 generations on · 1 of its ownK191601 Valleylab FT10 Electrosurgical PlatformCovidien · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK241085 Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN…Covidien, LLC · 2024
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 backK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
- 3 generations backK040641 Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8…Epicor Medical, Inc. · 2004
- 2 generations backK043579 Atricure Bipolar SystemAtriCure, Inc. · 2007
- 1 generation backK080509 Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP…Medtronic, Inc. · 2008
- This deviceK093203 Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models…Medtronic, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic · 2018 · cites it directly2descendants
- K191601Valleylab FT10 Electrosurgical PlatformCovidien · 2019 · 2 generations on1descendant
- K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC · 2024 · 3 generations on0descendants
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 | K022894 | Epicor Medical Ablation System | Epicor Medical, Inc. | 2004 | — |
| −3 | K040641 | Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9… | Epicor Medical, Inc. | 2004 | — |
| −2 | K043579 | Atricure Bipolar System | AtriCure, Inc. | 2007 | — |
| −1 | K080509 | Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation… | Medtronic, Inc. | 2008 | — |
| 0 (this device) | K093203 | Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831… | Medtronic, Inc. | 2010 | — |
| +1 | K182610 | Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation… | Medtronic | 2018 | — |
| +2 | K191601 | Valleylab FT10 Electrosurgical Platform | Covidien | 2019 | 1 |
| +3 | K241085 | Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN… | Covidien, LLC | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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 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 |
|---|---|---|---|
| * | K080509 | Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device…Summary page 1…tion Number: 21 CFR 878.4400 Product Code: GEI Classification: Class II Predicate Device Cardiobiate® Surgical Ablation System (K080509) Device Description The Medtronic Cardioblate® Surgical Ablation System consists of areusable radiofrequency generator which ca… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182610 | Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device… | 2018 | 2 |
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 1.8 years on median.
- 3 of the 55 ancestors have a recall of any class.
- Of its descendants, K182610 (Medtronic, 2018) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K080509.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Medtronic Cardioblate® System is intended to ablate cardiac tissue during cardiac surgery using radiofirequency energy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093203: Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093203
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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