510(k) · Cleared
Recalled · 2010Modification to: Cardima 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 May 15, 2006 as substantially equivalent to K022008 (Cardima, Inc., 2003) after a 59-day review. Its family tree reaches back 3 generations to 1992. It has been recalled 2 times.
- Decided
- May 15, 2006
- Review
- 59 days
- Class
- Class II
- Product code
- OCL
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K921884 (1992). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK921884 FORCE 2Valleylab, Inc. · 1992
- 2 generations backK013392 Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate…Medtronic Vascular · 2002 · Recalled
- 1 generation backK022008 Cardima Ablation SystemCardima, Inc. · 2003 · Recalled
- This deviceK060715 Modification to: Cardima Ablation SystemCardima, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921884 | FORCE 2 | Valleylab, Inc. | 1992 | — |
| −2 | K013392 | Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation… | Medtronic Vascular | 2002 | 1 |
| −1 | K022008 | Cardima Ablation System | Cardima, Inc. | 2003 | 2 |
| 0 (this device) | K060715 | Modification to: Cardima Ablation System | Cardima, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 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? (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 |
|---|---|---|---|
| * | K022008 | Cardima Ablation SystemSummary page 1…FR 870.4400) Equivalent Device: The subject device and accessory are substantially equivalent in intended use and/or method of operation to the Cardima Ablation System (K022008) Intended Use: The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency ener… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K022008.
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/K060715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060715: Modification to: 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/K060715
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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