510(k) · Cleared
Recalled · 2002Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Cleared on Jan 25, 2002 as substantially equivalent to K010662 (Tissuelink Medical, Inc., 2001) and 4 other predicates after a 102-day review. Its family tree reaches back 1 generation to 1992. 102 later devices descend from it. It has been recalled once.
- Decided
- Jan 25, 2002
- Review
- 102 days
- Class
- Class II
- Product code
- OCL
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 1 generation to K921884 (1992). 5 ancestors in all. 102 later devices descend from it, 12 citing it directly.
- Root · 1 generation backK921884 FORCE 2Valleylab, Inc. · 1992
- This deviceK013392 Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate…Medtronic Vascular · 2002
- Descendant · cites it directly · 61 of its ownK013873 Cobra Cardiac Electrosurgical SystemBoston Scientific Corp · 2002
- Descendant · 2 generations on · 46 of its ownK023288 Cobra Bipolar Clamp, Model 15902Boston Scientific EP Technologies · 2003
- Descendant · cites it directly · 42 of its ownK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
- Descendant · cites it directly · 34 of its ownK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
- Descendant · cites it directly · 25 of its ownK022008 Cardima Ablation SystemCardima, Inc. · 2003 · Recalled
Showing 5 of 102 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 102 · See all- K013873Cobra Cardiac Electrosurgical SystemBoston Scientific Corp · 2002 · cites it directly61descendants
- K023288Cobra Bipolar Clamp, Model 15902Boston Scientific EP Technologies · 2003 · 2 generations on46descendants
- K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 2004 · cites it directly42descendants
- K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003 · cites it directly34descendants
- K022008Cardima Ablation SystemCardima, Inc. · 2003 · cites it directly25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921884 | FORCE 2 | Valleylab, Inc. | 1992 | — |
| 0 (this device) | K013392 | Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation… | Medtronic Vascular | 2002 | — |
| +1 | K013873 | Cobra Cardiac Electrosurgical System | Boston Scientific Corp | 2002 | — |
| +2 | K023288 | Cobra Bipolar Clamp, Model 15902 | Boston Scientific EP Technologies | 2003 | — |
| +1 | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical… | Cryocath Technologies, Inc. | 2004 | — |
| +1 | K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation System | Medtronic Vascular | 2003 | — |
| +1 | K022008 | Cardima Ablation System | Cardima, Inc. | 2003 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 13 | 0 |
| 2007 | 5 | 0 |
| 2008 | 10 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 8 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 6 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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? (5)
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 |
|---|---|---|---|
| * | K010662 | Modification to Tissuelink Monopolar Floating BallSummary page 1…ification Name: Electrosurgical Cutting, and Coagulation Device and Accessories Classification: Class IT, 21 CFR 878.4400 Predicate Devices: TissueLink™ Floating Ball (K010662), Boston Scientific Cobra RF System (K010956), EndoCare Cryocare Cardiac Surgical System (K011040), AFx Microwave Flex Ablation W… | 2001 |
| * | K010956 | Cobra 1/2 Flex Surgical Probe, Model 1593X; Cobra Flex Surgical Probe Model 1594XSummary page 1…Coagulation Device and Accessories Classification: Class IT, 21 CFR 878.4400 Predicate Devices: TissueLink™ Floating Ball (K010662), Boston Scientific Cobra RF System (K010956), EndoCare Cryocare Cardiac Surgical System (K011040), AFx Microwave Flex Ablation Wand System (K003978), and ValleyLab Force 2 E… | 2001 |
| * | K011040 | Cryocare Cardiac Surgical SystemSummary page 1…ass IT, 21 CFR 878.4400 Predicate Devices: TissueLink™ Floating Ball (K010662), Boston Scientific Cobra RF System (K010956), EndoCare Cryocare Cardiac Surgical System (K011040), AFx Microwave Flex Ablation Wand System (K003978), and ValleyLab Force 2 Electrosurgical Generator (K921884). Device Descripti… | 2001 |
| * | K003978 | Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N…Summary page 1…Link™ Floating Ball (K010662), Boston Scientific Cobra RF System (K010956), EndoCare Cryocare Cardiac Surgical System (K011040), AFx Microwave Flex Ablation Wand System (K003978), and ValleyLab Force 2 Electrosurgical Generator (K921884). Device Description: The Medtronic Cardioblate System is comprised o… | 2001 |
| * | K921884 | FORCE 2Summary page 1…ystem (K010956), EndoCare Cryocare Cardiac Surgical System (K011040), AFx Microwave Flex Ablation Wand System (K003978), and ValleyLab Force 2 Electrosurgical Generator (K921884). Device Description: The Medtronic Cardioblate System is comprised of a radiofrequency ablation pen, radiofrequency generator,… | 1992 |
What descends from it? (102)
See all 10212 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013873 | Cobra Cardiac Electrosurgical System | 2002 | 61 |
| K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console | 2004 | 42 |
| K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation System | 2003 | 34 |
| K022008 | Cardima Ablation System | 2003 | 25 |
| K022894 | Epicor Medical Ablation System | 2004 | 23 |
| K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical… | 2006 | 22 |
| K043579 | Atricure Bipolar System | 2007 | 18 |
| K050459 | Atricure Isolator Transpolar Pen | 2005 | 18 |
| K073605 | Atricure Coolrail Linear Pen | 2008 | 13 |
| K080509 | Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device… | 2008 | 10 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 11, 2002 | Not classified | Z-0351-03 | Other | The radio frequency ablation pens contained unreacted epoxy resin which was observed to leak out of the back-end of the device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 5 ancestors has a recall.
- Of its descendants, K013873 (Boston Scientific Corp, 2002) has gone furthest, with 61 descendants of its own.
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.
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 Medtronic® Cardioblate™ Radiofrequency Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
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/K013392 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013392: Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013392
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026