510(k) · Cleared
Recalled · Class II · 2019Epi-Sense Guided Coagulation Device with Visitrax
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ncontact Surgical, Inc. · OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Cleared on Oct 28, 2014 as substantially equivalent to K120857 (Ncontact Surgical, Inc., 2012) after an 89-day review. Its family tree reaches back 11 generations to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 28, 2014
- Review
- 89 days
- Class
- Class II
- Product code
- OCL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 11 generations to K942299 (1995). 58 ancestors in all, the oldest K811390 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 7 generations between
- 3 generations backK100501 Multifunctional Linear PenAtriCure, Inc. · 2010
- 2 generations backK113475 Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech · 2012 · Recalled
- 1 generation backK120857 Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2012
- This deviceK142084 Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK193162 EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc. · 2019
Show all 11 generations
- Root · 11 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 10 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 9 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 8 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 7 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 6 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 5 generations backK050459 Atricure Isolator Transpolar PenAtriCure, Inc. · 2005 · Recalled
- 4 generations backK061593 Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and…AtriCure, Inc. · 2006 · Recalled
- 3 generations backK100501 Multifunctional Linear PenAtriCure, Inc. · 2010
- 2 generations backK113475 Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech · 2012 · Recalled
- 1 generation backK120857 Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2012
- This deviceK142084 Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −10 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −9 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −8 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −7 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −6 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −5 | K050459 | Atricure Isolator Transpolar Pen | AtriCure, Inc. | 2005 | 1 |
| −4 | K061593 | Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1 | AtriCure, Inc. | 2006 | 1 |
| −3 | K100501 | Multifunctional Linear Pen | AtriCure, Inc. | 2010 | — |
| −2 | K113475 | Estech Cobra Adhere XL 2 Surgical System | Endoscopic Technologies, Inc. D/B/A Estech | 2012 | 5 |
| −1 | K120857 | Epi-Sense Guided Coagulation Device with Visitrax | Ncontact Surgical, Inc. | 2012 | — |
| 0 (this device) | K142084 | Epi-Sense Guided Coagulation Device with Visitrax | Ncontact Surgical, Inc. | 2014 | — |
| +1 | 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 |
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 |
|---|---|---|---|
| * | K120857 | Epi-Sense Guided Coagulation Device with VisitraxSummary page 4…numbers: CDK-1411; CDK-1412; CDK-1413 Legally Marketed unmodified K120857 cleared Nov. 13, 2012 device 510k number VOL_003_510k Summary_001_Summary Page 3-1 of 3-3… | 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 |
|---|---|---|---|
| K193162 | EPi-Sense Guided Coagulation System with VisiTrax | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 29, 2019 | Class II | Z-1887-2019 | Process control | The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case reasonable harm of infection if used. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 58 ancestors have a recall of any class.
- Of its descendants, K193162 (AtriCure, 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. 2014, 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/K142084 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142084: Epi-Sense Guided Coagulation Device 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/K142084
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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