510(k) · Cleared
ClearedCardioblate Cryoflex Surgical Ablation Probes
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 Nov 2, 2012 as substantially equivalent to K053436 (Cryocath Technologies, Inc., 2006) after a 127-day review. Its family tree reaches back 8 generations to 1995. 2 later devices descend from it.
- Decided
- Nov 2, 2012
- Review
- 127 days
- Class
- Class II
- Product code
- OCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K942299 (1995). 44 ancestors in all, the oldest K811390 (1981). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 7 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 6 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 5 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 4 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 3 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 2 generations backK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
- 1 generation backK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled
- This deviceK121878 Cardioblate Cryoflex Surgical Ablation ProbesMedtronic, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK123733 Cardioblate Cryoflex Surgical Ablation SystemMedtronic, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK191526 Cardioblate CryoFlex Surgical Ablation SystemMedtronic, Inc. · 2019
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 |
|---|---|---|---|---|---|
| −8 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −7 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −6 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −5 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −4 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −3 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −2 | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical… | Cryocath Technologies, Inc. | 2004 | — |
| −1 | K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and… | Cryocath Technologies, Inc. | 2006 | 1 |
| 0 (this device) | K121878 | Cardioblate Cryoflex Surgical Ablation Probes | Medtronic, Inc. | 2012 | — |
| +1 | K123733 | Cardioblate Cryoflex Surgical Ablation System | Medtronic, Inc. | 2013 | 5 |
| +2 | K191526 | Cardioblate CryoFlex Surgical Ablation System | Medtronic, Inc. | 2019 | — |
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 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…Summary page 1…Product Code: OCL Predicate Device Surgirost 7cm, 10cm Cryosurgical Devices (K053436) Special 510(k): Modification to K053436 Page 15 of 95 Medtronic === Page 2… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123733 | Cardioblate Cryoflex Surgical Ablation System | 2013 | 1 |
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 17 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 44 ancestors have a recall of any class.
- Of its descendants, K123733 (Medtronic, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K053436.
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 Cryolex Surgical Ablation System is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate Cryolex 7 cm, 10 cm, and 10-S probes plus the Clamp and Surgical Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121878: Cardioblate Cryoflex Surgical Ablation Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121878
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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