510(k) · Cleared
Recalled · Class II · 2022Cardioblate Gemini Surgical Ablation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Cleared on Jul 13, 2012 as substantially equivalent to K080509 (Medtronic, Inc., 2008) after a 28-day review. Its family tree reaches back 10 generations to 1995. 2 later devices descend from it. It has been recalled once.
- Decided
- Jul 13, 2012
- Review
- 28 days
- Class
- Class II
- Product code
- OCL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 10 generations to K942299 (1995). 55 ancestors in all, the oldest K811390 (1981). 2 later devices descend from it, 2 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 deviceK121767 Cardioblate Gemini Surgical Ablation DeviceMedtronic, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK200514 Cardioblate Gemini-s Surgical Ablation DeviceMedtronic · 2020 · Recalled
- Descendant · cites it directly · 0 of its ownK223508 Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate…Medtronic, Inc. · 2022
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 deviceK121767 Cardioblate Gemini Surgical Ablation DeviceMedtronic, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView 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) | K121767 | Cardioblate Gemini Surgical Ablation Device | Medtronic, Inc. | 2012 | — |
| +1 | K200514 | Cardioblate Gemini-s Surgical Ablation Device | Medtronic | 2020 | 1 |
| +1 | K223508 | Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s… | Medtronic, Inc. | 2022 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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 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? (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 2…ice. The current device is substantially equivalent to the previously submitted and approved predicate Cardioblatel Gemini® Surgical Ablation Device, Models 49260/49261 (K080509). Medtoni ConidetialT~ae 242 CardloblateO Gemi… | 2008 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 20, 2022 | Class II | Z-1131-2022 | Labeling design | Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 55 ancestors have a recall of any class.
- Of its descendants, K200514 (Medtronic, 2020) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K080509.
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. 2012, this device’s year, is highlighted.
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 Cardioblate® Gemnini® Surgical Ablation Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121767 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121767: Cardioblate Gemini Surgical Ablation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121767
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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