510(k) · Cleared
Recalled · 2009Epicor Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Cleared on Jul 25, 2008 as substantially equivalent to K022894 (Epicor Medical, Inc., 2004) and 1 other predicate after a 172-day review. Its family tree reaches back 8 generations to 1995. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jul 25, 2008
- Review
- 172 days
- Class
- Class II
- Product code
- OCL
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 8 generations to K942299 (1995). 50 ancestors in all, the oldest K811390 (1981). 1 later device descends 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 backK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
- 1 generation backK040641 Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8…Epicor Medical, Inc. · 2004
- This deviceK080292 Epicor Ablation SystemSt Jude Medical · 2008
- Descendant · cites it directly · 0 of its ownK082279 Epicor Ablation Control System, Model Acs-US-2, Acs-Eur-2St Jude Medical · 2008
Most influential descendants
Showing 1 of 1 · See all- K082279Epicor Ablation Control System, Model Acs-US-2, Acs-Eur-2St Jude Medical · 2008 · cites it directly0descendants
View 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 | K022894 | Epicor Medical Ablation System | Epicor Medical, Inc. | 2004 | — |
| −1 | K040641 | Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9… | Epicor Medical, Inc. | 2004 | — |
| 0 (this device) | K080292 | Epicor Ablation System | St Jude Medical | 2008 | — |
| +1 | K082279 | Epicor Ablation Control System, Model Acs-US-2, Acs-Eur-2 | St Jude Medical | 2008 | — |
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 | 4 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (2)
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 |
|---|---|---|---|
| * | K022894 | Epicor Medical Ablation SystemSummary page 1…ation, Ultrasound and Accessories (21 CFR 878.4400) Predicate Device: Epicor Ablation Control System (ACS) K022894 UltraCinch Tissue Ablation Device K040641 UltraWand Ablation Devi… | 2004 |
| * | K040641 | Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Summary page 1…icate Device: Epicor Ablation Control System (ACS) K022894 UltraCinch Tissue Ablation Device K040641 UltraWand Ablation Device K022894 UltraCinch Accessory Pa… | 2004 |
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 |
|---|---|---|---|
| K082279 | Epicor Ablation Control System, Model Acs-US-2, Acs-Eur-2 | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 15, 2009 | Not classified | Z-1780-2010 | Other | The firm states that overheating of cardiac tissue is caused by inadequate cooling. The potential exists when the UltraWand is run using off-label cooling methods (gravity saline flow instead of pump) that cooling flow to one or both… |
| Dec 9, 2008 | Not classified | Z-0946-2009 | Other | Firm has received multiple reports of difficulties connecting the product and/or the presence of error code messages occurring with the use of the connecting cable and the Ablation Control System unit. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 50 ancestors have a recall of any class.
- Of its descendants, K082279 (St Jude Medical, 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K022894.
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. 2008, 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 Epicor Medical Ablation Control System is intended for the ablation of cardiac tissue during cardiac surgery The UltraCinch LP is intended for the ablation of cardiac tissue during cardiac surgery The UltraWand LP is intended for the ablation of cardiac tissue during cardiac surgery The items in LP PAS System are part of the Epicor Cardiac Ablation System. The System is intended for the ablation of cardiac tissue during cardiac surgery The LP Oblique…
Read the full statement (122 words)
The Epicor Medical Ablation Control System is intended for the ablation of cardiac tissue during cardiac surgery
The UltraCinch LP is intended for the ablation of cardiac tissue during cardiac surgery
The UltraWand LP is intended for the ablation of cardiac tissue during cardiac surgery
The items in LP PAS System are part of the Epicor Cardiac Ablation System. The System is intended for the ablation of cardiac tissue during cardiac surgery
The LP Oblique Introducer is part of the Epicor Cardiac Ablation System. The System is intended for the ablation of cardiac tissue during cardiac surgery
The LP Connecting Cable is part of the Epicor Cardiac Ablation System. The System is intended for the ablation of cardiac tissue during cardiac surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080292 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080292: Epicor Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080292
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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