510(k) · Cleared
ClearedEpicor Medical Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epicor Medical, Inc. · NTB System, Ablation, Ultrasound And Accessories
Cleared on Feb 26, 2004 as substantially equivalent to K010956 (Boston Scientific Corp, 2001) and 8 other predicates after a 541-day review. Its family tree reaches back 6 generations to 1995. 23 later devices descend from it.
- Decided
- Feb 26, 2004
- Review
- 541 days
- Class
- Class II
- Product code
- NTB
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 6 generations to K942299 (1995). 47 ancestors in all, the oldest K811390 (1981). 23 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 5 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 4 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 3 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 2 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 1 generation backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- This deviceK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
- Descendant · cites it directly · 22 of its ownK040641 Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8…Epicor Medical, Inc. · 2004
- Descendant · 2 generations on · 18 of its ownK043579 Atricure Bipolar SystemAtriCure, Inc. · 2007
- Descendant · 3 generations on · 10 of its ownK080509 Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP…Medtronic, Inc. · 2008
- Descendant · 3 generations on · 6 of its ownK101174 Atricure Bipolar System Including Isolator Synergy Dual Electrode…AtriCure, Inc. · 2010
- Descendant · 3 generations on · 5 of its ownK110117 Atricure Bipolar SystemAtriCure, Inc. · 2011
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc. · 2004 · cites it directly22descendants
- K043579Atricure Bipolar SystemAtriCure, Inc. · 2007 · 2 generations on18descendants
- K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device…Medtronic, Inc. · 2008 · 3 generations on10descendants
- K101174Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…AtriCure, Inc. · 2010 · 3 generations on6descendants
- K110117Atricure Bipolar SystemAtriCure, Inc. · 2011 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −5 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −4 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −3 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −2 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −1 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| 0 (this device) | 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 | — |
| +2 | K043579 | Atricure Bipolar System | AtriCure, Inc. | 2007 | — |
| +3 | K080509 | Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation… | Medtronic, Inc. | 2008 | — |
| +3 | K101174 | Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model… | AtriCure, Inc. | 2010 | — |
| +3 | K110117 | Atricure Bipolar System | AtriCure, Inc. | 2011 | — |
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 | 3 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 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 NTB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (10)
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 |
|---|---|---|---|
| * | K010956 | Cobra 1/2 Flex Surgical Probe, Model 1593X; Cobra Flex Surgical Probe Model 1594X | 2001 |
| * | K013873 | Cobra Cardiac Electrosurgical SystemSummary page 4…evice: The subject device is substantially equivalent in intended use and/or method of operation to the Boston Scientific Cobra Flex Family of Surgical Probes (KO 10956, K013873), the AtriCure Coagulation System (KO I1722, K020919); the AFx Microwave Ablation System (K003978, K013946); the Medtronic Cardio… | 2002 |
| * | K011722 | Atricure Bipolar Coagulation System | 2001 |
| * | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1Summary page 4…in intended use and/or method of operation to the Boston Scientific Cobra Flex Family of Surgical Probes (KO 10956, K013873), the AtriCure Coagulation System (KO I1722, K020919); the AFx Microwave Ablation System (K003978, K013946); the Medtronic Cardioblate Radiofrequency Ablation System (KO13392); Cardi… | 2002 |
| * | K003978 | Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N…Summary page 4…o the Boston Scientific Cobra Flex Family of Surgical Probes (KO 10956, K013873), the AtriCure Coagulation System (KO I1722, K020919); the AFx Microwave Ablation System (K003978, K013946); the Medtronic Cardioblate Radiofrequency Ablation System (KO13392); CardioFocus Malleable Surgical Lightstic (K013901)… | 2001 |
| * | K013946 | Flex 10 Accessory for the Afx Microwave Ablation SystemSummary page 4…ton Scientific Cobra Flex Family of Surgical Probes (KO 10956, K013873), the AtriCure Coagulation System (KO I1722, K020919); the AFx Microwave Ablation System (K003978, K013946); the Medtronic Cardioblate Radiofrequency Ablation System (KO13392); CardioFocus Malleable Surgical Lightstic (K013901); the Cry… | 2002 |
| * | K013392 | Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation… | 2002 |
| * | K013901 | Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Summary page 4…919); the AFx Microwave Ablation System (K003978, K013946); the Medtronic Cardioblate Radiofrequency Ablation System (KO13392); CardioFocus Malleable Surgical Lightstic (K013901); the CryoCath SurgiFrost probe (K021010) and the Cardima Ablation System (K022008). Intended Use: The Epicor Medical Ablation S… | 2001 |
| Kept off the family tree | K021010 | FDA’s K021010 is Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSE Our reading of the summary gave K021010, FDA’s number for Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSE (Endocare, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “CryoCath SurgiFrost probe”. Kept off the family tree. Summary page 4…K003978, K013946); the Medtronic Cardioblate Radiofrequency Ablation System (KO13392); CardioFocus Malleable Surgical Lightstic (K013901); the CryoCath SurgiFrost probe (K021010) and the Cardima Ablation System (K022008). Intended Use: The Epicor Medical Ablation System (the UltraWand Ablation Device, Abl… | 2002 |
| * | K022008 | Cardima Ablation System Cleared while this submission was under review Summary page 4…te Radiofrequency Ablation System (KO13392); CardioFocus Malleable Surgical Lightstic (K013901); the CryoCath SurgiFrost probe (K021010) and the Cardima Ablation System (K022008). Intended Use: The Epicor Medical Ablation System (the UltraWand Ablation Device, Ablation Control System, and Connecting Cable… | 2003 |
What descends from it? (23)
See all 232 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)
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 9 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 47 ancestors have a recall of any class.
- Of its descendants, K040641 (Epicor Medical, Inc., 2004) has gone furthest, with 22 descendants of its own.
- 2 other devices also cite its predicate K010956.
How does its category compare?
All NTB devicesNTB System, Ablation, Ultrasound And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NTB
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · NTB
Too few NTB 510(k)s in any year since 2007 to give a median.
Recalls per year · NTB
No recall names NTB since 2007.
Adverse event reports per year · NTB
2in 2012
MAUDE reports naming product code NTB, 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 | 0 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 19 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Epicor Medical Ablation System (the UltraWand Ablation Device, Ablation Control System, and Connecting Cable) is Intended for the ablation of cardiac tissue during cardiac surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K022894 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022894: Epicor Medical Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022894
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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