510(k) · Cleared
ClearedCardioblate Bipolar Radiofrequency Surgical Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 17, 2003 as substantially equivalent to K013392 (Medtronic Vascular, 2002) and 1 other predicate after a 90-day review. Its family tree reaches back 6 generations to 1995. 34 later devices descend from it.
- Decided
- Jul 17, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K942299 (1995). 38 ancestors in all, the oldest K811390 (1981). 34 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 5 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 4 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 3 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 2 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 1 generation backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- This deviceK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
- Descendant · cites it directly · 14 of its ownK060054 Oncobionic SystemOncobionics, Inc. · 2006
- Descendant · cites it directly · 14 of its ownK060400 Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate…Medtronic, Inc. · 2006
- Descendant · 2 generations on · 11 of its ownK080202 Oncobionic System with 6 Probe OutputOncobionics, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 11 of its ownK080376 Oncobionic SystemOncobionic Incorporated · 2008 · Recalled
- Descendant · 3 generations on · 10 of its ownK102329 Nanoknife SystemAngioDynamics, Inc. · 2011 · Recalled
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K060054Oncobionic SystemOncobionics, Inc. · 2006 · cites it directly14descendants
- K060400Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation…Medtronic, Inc. · 2006 · cites it directly14descendants
- K080202Oncobionic System with 6 Probe OutputOncobionics, Inc. · 2008 · 2 generations on11descendants
- K080376Oncobionic SystemOncobionic Incorporated · 2008 · 2 generations on11descendants
- K102329Nanoknife SystemAngioDynamics, Inc. · 2011 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −5 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −4 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −3 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −2 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −1 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| 0 (this device) | K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation System | Medtronic Vascular | 2003 | — |
| +1 | K060054 | Oncobionic System | Oncobionics, Inc. | 2006 | — |
| +1 | K060400 | Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical… | Medtronic, Inc. | 2006 | — |
| +2 | K080202 | Oncobionic System with 6 Probe Output | Oncobionics, Inc. | 2008 | 1 |
| +2 | K080376 | Oncobionic System | Oncobionic Incorporated | 2008 | 1 |
| +3 | K102329 | Nanoknife System | AngioDynamics, Inc. | 2011 | 1 |
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 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (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.
What descends from it? (34)
See all 344 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 8 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 38 ancestors have a recall of any class.
- Of its descendants, K060054 (Oncobionics, Inc., 2006) has gone furthest, with 14 descendants of its own.
- 11 other devices also cite its predicate K013392.
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 Medtronim CardioblateB Bipolar Radiofrequency Ablation 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/K031247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031247: Cardioblate Bipolar Radiofrequency Surgical Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031247
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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