510(k) · Cleared
ClearedEPi-Sense Guided Coagulation System with VisiTrax
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AtriCure, Inc. · OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Cleared on Dec 13, 2019 as substantially equivalent to K142084 (Ncontact Surgical, Inc., 2014) after a 28-day review. Its family tree reaches back 12 generations to 1995.
- Decided
- Dec 13, 2019
- Review
- 28 days
- Class
- Class II
- Product code
- OCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K942299 (1995). 59 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.
- Root · 12 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 8 generations between
- 3 generations backK113475 Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech · 2012 · Recalled
- 2 generations backK120857 Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2012
- 1 generation backK142084 Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2014 · Recalled
- This deviceK193162 EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc. · 2019
Show all 12 generations
- Root · 12 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 11 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 10 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 9 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 8 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 7 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 6 generations backK050459 Atricure Isolator Transpolar PenAtriCure, Inc. · 2005 · Recalled
- 5 generations backK061593 Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and…AtriCure, Inc. · 2006 · Recalled
- 4 generations backK100501 Multifunctional Linear PenAtriCure, Inc. · 2010
- 3 generations backK113475 Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech · 2012 · Recalled
- 2 generations backK120857 Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2012
- 1 generation backK142084 Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2014 · Recalled
- This deviceK193162 EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −11 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −10 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −9 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −8 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −7 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −6 | K050459 | Atricure Isolator Transpolar Pen | AtriCure, Inc. | 2005 | 1 |
| −5 | K061593 | Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1 | AtriCure, Inc. | 2006 | 1 |
| −4 | K100501 | Multifunctional Linear Pen | AtriCure, Inc. | 2010 | — |
| −3 | K113475 | Estech Cobra Adhere XL 2 Surgical System | Endoscopic Technologies, Inc. D/B/A Estech | 2012 | 5 |
| −2 | K120857 | Epi-Sense Guided Coagulation Device with Visitrax | Ncontact Surgical, Inc. | 2012 | — |
| −1 | K142084 | Epi-Sense Guided Coagulation Device with Visitrax | Ncontact Surgical, Inc. | 2014 | 1 |
| 0 (this device) | K193162 | EPi-Sense Guided Coagulation System with VisiTrax | AtriCure, 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 | 8 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K142084 | Epi-Sense Guided Coagulation Device with VisitraxSummary page 4…Classification Panel: Cardiovascular Predicate Device: EPi-Sense Guided Coagulation System with VisiTrax (K142084, 28 October 2014) III. Device Description The EPi-Sense Guided Coagulation System flexible, cooled electrode device, wit… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 59 ancestors have a recall of any class.
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. 2019, 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 EPi-Sense Guided Coagulation System with VisiTrax is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques.
The EPi-Sense Guided Coagulation System with VisiTrax may be used for temporary cardiac signal sensing and recording during surgery when connected to an external recording device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193162: EPi-Sense Guided Coagulation System with VisiTrax.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193162
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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