510(k) · Cleared
ClearedUltracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-Acc-1
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 May 5, 2004 as substantially equivalent to K022894 (Epicor Medical, Inc., 2004) and 6 other predicates after a 56-day review. Its family tree reaches back 7 generations to 1995. 22 later devices descend from it.
- Decided
- May 5, 2004
- Review
- 56 days
- Class
- Class II
- Product code
- NTB
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 7 generations to K942299 (1995). 49 ancestors in all, the oldest K811390 (1981). 22 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 6 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 5 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 4 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 3 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 2 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 1 generation backK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
- This deviceK040641 Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8…Epicor Medical, Inc. · 2004
- Descendant · cites it directly · 18 of its ownK043579 Atricure Bipolar SystemAtriCure, Inc. · 2007
- Descendant · 2 generations on · 10 of its ownK080509 Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP…Medtronic, Inc. · 2008
- Descendant · 2 generations on · 6 of its ownK101174 Atricure Bipolar System Including Isolator Synergy Dual Electrode…AtriCure, Inc. · 2010
- Descendant · 2 generations on · 5 of its ownK110117 Atricure Bipolar SystemAtriCure, Inc. · 2011
- Descendant · 3 generations on · 3 of its ownK093203 Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models…Medtronic, Inc. · 2010
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K043579Atricure Bipolar SystemAtriCure, Inc. · 2007 · cites it directly18descendants
- K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device…Medtronic, Inc. · 2008 · 2 generations on10descendants
- K101174Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…AtriCure, Inc. · 2010 · 2 generations on6descendants
- K110117Atricure Bipolar SystemAtriCure, Inc. · 2011 · 2 generations on5descendants
- K093203Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841Medtronic, Inc. · 2010 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −6 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −5 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −4 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −3 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −2 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −1 | K022894 | Epicor Medical Ablation System | Epicor Medical, Inc. | 2004 | — |
| 0 (this device) | K040641 | Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9… | Epicor Medical, Inc. | 2004 | — |
| +1 | K043579 | Atricure Bipolar System | AtriCure, Inc. | 2007 | — |
| +2 | K080509 | Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation… | Medtronic, Inc. | 2008 | — |
| +2 | K101174 | Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model… | AtriCure, Inc. | 2010 | — |
| +2 | K110117 | Atricure Bipolar System | AtriCure, Inc. | 2011 | — |
| +3 | K093203 | Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831… | Medtronic, Inc. | 2010 | — |
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 |
|---|---|---|
| 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? (8)
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 |
|---|---|---|---|
| * | K022894 | Epicor Medical Ablation SystemSummary page 4…nts Equivalent Device: The subject device is substantially equivalent in intended use and/or method of operation to the Epicor Medical UltraWand tissue ablation device (K022894), the Medtronic Cardioblate Radiofrequency Ablation System (KG 13392), the Boston Scientific Cobra RF and Cooled RF Family of Sur… | 2004 |
| Kept off the family tree | K031392 | FDA’s K031392 is Mas Tox Ammonia Controlliquid Assayed Tox Ammonia Control Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2003 |
| * | K013873 | Cobra Cardiac Electrosurgical SystemSummary page 4…e ablation device (K022894), the Medtronic Cardioblate Radiofrequency Ablation System (KG 13392), the Boston Scientific Cobra RF and Cooled RF Family of Surgical Probes (K013873, K02329 1), the AFx Microwave Ablation System (K003978, K01 3946), and the CardioFocus Surgical Lightstic (KOl1 1988, K01 390 1).… | 2002 |
| * | K023291 | Cobra Cooled Cardiac Surgical Probe, Model 1596XSummary page 4…n device (K022894), the Medtronic Cardioblate Radiofrequency Ablation System (KG 13392), the Boston Scientific Cobra RF and Cooled RF Family of Surgical Probes (K013873, K02329 1), the AFx Microwave Ablation System (K003978, K01 3946), and the CardioFocus Surgical Lightstic (KOl1 1988, K01 390 1). Intended… | 2002 |
| * | K003978 | Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N…Summary page 4…Radiofrequency Ablation System (KG 13392), the Boston Scientific Cobra RF and Cooled RF Family of Surgical Probes (K013873, K02329 1), the AFx Microwave Ablation System (K003978, K01 3946), and the CardioFocus Surgical Lightstic (KOl1 1988, K01 390 1). Intended Use: The Epicor Medical UltraCinch is intend… | 2001 |
| * | K013946 | Flex 10 Accessory for the Afx Microwave Ablation SystemSummary page 4…uency Ablation System (KG 13392), the Boston Scientific Cobra RF and Cooled RF Family of Surgical Probes (K013873, K02329 1), the AFx Microwave Ablation System (K003978, K01 3946), and the CardioFocus Surgical Lightstic (KOl1 1988, K01 390 1). Intended Use: The Epicor Medical UltraCinch is intended for the… | 2002 |
| * | K011988 | Surgical Lightstic 180, Model 180 L, Model 180 C | 2001 |
| * | K013901 | Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Summary page 4…RF and Cooled RF Family of Surgical Probes (K013873, K02329 1), the AFx Microwave Ablation System (K003978, K01 3946), and the CardioFocus Surgical Lightstic (KOl1 1988, K01 390 1). Intended Use: The Epicor Medical UltraCinch is intended for the ablation of cardiac tissue during cardiac surgery. The items… | 2001 |
What descends from it? (22)
See all 223 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 1.0 years on median.
- 3 of the 49 ancestors have a recall of any class.
- Of its descendants, K043579 (AtriCure, Inc., 2007) has gone furthest, with 18 descendants of its own.
- 1 other device also cites its predicate K022894.
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 UltraCinch is intended for the ablation of cardiac tissue during cardiac surgery.
The items in the UltraCinch Accessory Pack are intended for use in 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/K040641 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040641: Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-Acc-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040641
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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