510(k) · Cleared
Recalled · 2010Cardima Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardima, Inc. · OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Cleared on Jan 29, 2003 as substantially equivalent to K981981 (Boston Scientific Corp, 1998) and 1 other predicate after a 224-day review. Its family tree reaches back 2 generations to 1992. 25 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 29, 2003
- Review
- 224 days
- Class
- Class II
- Product code
- OCL
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 2 generations to K921884 (1992). 7 ancestors in all. 25 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK921884 FORCE 2Valleylab, Inc. · 1992
- 1 generation backK013392 Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate…Medtronic Vascular · 2002 · Recalled
- This deviceK022008 Cardima Ablation SystemCardima, Inc. · 2003
- Descendant · cites it directly · 23 of its ownK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
- Descendant · 2 generations on · 22 of its ownK040641 Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8…Epicor Medical, Inc. · 2004
- Descendant · 3 generations on · 18 of its ownK043579 Atricure Bipolar SystemAtriCure, Inc. · 2007
- Descendant · 4 generations on · 10 of its ownK080509 Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP…Medtronic, Inc. · 2008
- Descendant · 4 generations on · 6 of its ownK101174 Atricure Bipolar System Including Isolator Synergy Dual Electrode…AtriCure, Inc. · 2010
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K022894Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004 · cites it directly23descendants
- K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc. · 2004 · 2 generations on22descendants
- K043579Atricure Bipolar SystemAtriCure, Inc. · 2007 · 3 generations on18descendants
- K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device…Medtronic, Inc. · 2008 · 4 generations on10descendants
- K101174Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…AtriCure, Inc. · 2010 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921884 | FORCE 2 | Valleylab, Inc. | 1992 | — |
| −1 | K013392 | Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation… | Medtronic Vascular | 2002 | 1 |
| 0 (this device) | K022008 | Cardima Ablation System | Cardima, Inc. | 2003 | — |
| +1 | K022894 | Epicor Medical Ablation System | Epicor Medical, Inc. | 2004 | — |
| +2 | K040641 | Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9… | Epicor Medical, Inc. | 2004 | — |
| +3 | K043579 | Atricure Bipolar System | AtriCure, Inc. | 2007 | — |
| +4 | K080509 | Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation… | Medtronic, Inc. | 2008 | — |
| +4 | K101174 | Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model… | AtriCure, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 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 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981981 | Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical Unit (Esu) (230 Volt)…Summary page 1…ting Device Equivalent Device: The subject device is substantially equivalent in intended use and/or method of operation to the Boston Scientific Electrosurgical Probe (K981981), the AtriCure Bipolar Coagulator (KO?1722); and the Medtronic Cardioblate Surgical Ablation Pen (K013392). Intended Use: The Ca… | 1998 |
| Kept off the family tree | K021722 | AtriCure Bipolar Coagulator Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K013392 | Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation…Summary page 1…od of operation to the Boston Scientific Electrosurgical Probe (K981981), the AtriCure Bipolar Coagulator (KO?1722); and the Medtronic Cardioblate Surgical Ablation Pen (K013392). Intended Use: The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency ene… | 2002 |
What descends from it? (25)
See all 252 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 |
|---|---|---|---|---|
| May 20, 2010 | Not classified | Z-2580-2010 | Device Design | Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection. |
| May 20, 2010 | Not classified | Z-2581-2010 | Device Design | Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K022894 (Epicor Medical, Inc., 2004) has gone furthest, with 23 descendants of its own.
- 4 other devices also cite its predicate K981981.
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 Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022008: Cardima 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/K022008
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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