510(k) · Cleared
Recalled · Class II · 2021Cardioblate Cryoflex Surgical Ablation System
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 Apr 1, 2013 as substantially equivalent to K121878 (Medtronic, Inc., 2012) after a 117-day review. Its family tree reaches back 9 generations to 1995. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Apr 1, 2013
- Review
- 117 days
- Class
- Class II
- Product code
- OCL
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 9 generations to K942299 (1995). 45 ancestors in all, the oldest K811390 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 5 generations between
- 3 generations backK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
- 2 generations backK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled
- 1 generation backK121878 Cardioblate Cryoflex Surgical Ablation ProbesMedtronic, Inc. · 2012
- This deviceK123733 Cardioblate Cryoflex Surgical Ablation SystemMedtronic, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK191526 Cardioblate CryoFlex Surgical Ablation SystemMedtronic, Inc. · 2019
Show all 9 generations
- Root · 9 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 8 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 7 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 6 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 5 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 4 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 3 generations backK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
- 2 generations backK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled
- 1 generation backK121878 Cardioblate Cryoflex Surgical Ablation ProbesMedtronic, Inc. · 2012
- This deviceK123733 Cardioblate Cryoflex Surgical Ablation SystemMedtronic, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K191526Cardioblate CryoFlex Surgical Ablation SystemMedtronic, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −8 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −7 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −6 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −5 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −4 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −3 | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical… | Cryocath Technologies, Inc. | 2004 | — |
| −2 | K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and… | Cryocath Technologies, Inc. | 2006 | 1 |
| −1 | K121878 | Cardioblate Cryoflex Surgical Ablation Probes | Medtronic, Inc. | 2012 | — |
| 0 (this device) | K123733 | Cardioblate Cryoflex Surgical Ablation System | Medtronic, Inc. | 2013 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K121878 | Cardioblate Cryoflex Surgical Ablation ProbesSummary page 1…er 21 CFR 878.4350 Product Code: OCL Predicate Device CardioblateO CryoFlex® Surgical Ablation System (K12 1878) K123733 2/3 I. Device Description a. System an… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191526 | Cardioblate CryoFlex Surgical Ablation System | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2021 | Class II | Z-0273-2022 | Process control | There is potential for intermittent electrical connectivity between the console and probe. |
| Oct 12, 2020 | Class II | Z-0494-2021 | Under Investigation by firm | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices |
| Oct 12, 2020 | Class II | Z-0495-2021 | Under Investigation by firm | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices |
| Oct 12, 2020 | Class II | Z-0496-2021 | Under Investigation by firm | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices |
| Oct 12, 2020 | Class II | Z-0493-2021 | Under Investigation by firm | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 45 ancestors have a recall of any class.
- Of its descendants, K191526 (Medtronic, Inc., 2019) has gone furthest, with 0 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. 2013, 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 CryoFlex Surgical Ablation System is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate CryoFlex 7 cm, 10 cm, and 10-S probes plus CryoFlex 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/K123733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123733: Cardioblate Cryoflex Surgical 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/K123733
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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