510(k) · Cleared
ClearedNumeris Coagulation System with Visitrax, Model (S) CSK-021;CSK-022; CSK-023; CSK-025
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 Dec 30, 2008 as substantially equivalent to K063012 (Ncontact Surgical, Inc., 2006) after a 147-day review. Its family tree reaches back 5 generations to 1992. 4 later devices descend from it.
- Decided
- Dec 30, 2008
- Review
- 147 days
- Class
- Class II
- Product code
- OCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K921884 (1992). 11 ancestors in all, the oldest K870705 (1987). 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK921884 FORCE 2Valleylab, Inc. · 1992
- 4 generations backK013392 Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate…Medtronic Vascular · 2002 · Recalled
- 3 generations backK013873 Cobra Cardiac Electrosurgical SystemBoston Scientific Corp · 2002
- 2 generations backK053326 Estech Cobra Electrosurgical Unit & CableEndoscopic Technologies, Inc. · 2006
- 1 generation backK063012 Ncontact Coagulation System Kit, Model CSKNcontact Surgical, Inc. · 2006
- This deviceK082203 Numeris Coagulation System with Visitrax, Model (S) CSK-021;CSK-022…Ncontact Surgical, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK090202 Numeris Guided Coagulation System with Visitrax, Models CSK-121…Ncontact Surgical, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK120857 Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK142084 Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 0 of its ownK193162 EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K090202Numeris Guided Coagulation System with Visitrax, Models CSK-121, -122, -123 and -125Ncontact Surgical, Inc. · 2009 · cites it directly3descendants
- K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2012 · 2 generations on2descendants
- K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2014 · 3 generations on1descendant
- K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc. · 2019 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921884 | FORCE 2 | Valleylab, Inc. | 1992 | — |
| −4 | K013392 | Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation… | Medtronic Vascular | 2002 | 1 |
| −3 | K013873 | Cobra Cardiac Electrosurgical System | Boston Scientific Corp | 2002 | — |
| −2 | K053326 | Estech Cobra Electrosurgical Unit & Cable | Endoscopic Technologies, Inc. | 2006 | — |
| −1 | K063012 | Ncontact Coagulation System Kit, Model CSK | Ncontact Surgical, Inc. | 2006 | — |
| 0 (this device) | K082203 | Numeris Coagulation System with Visitrax, Model (S) CSK-021;CSK-022; CSK-023… | Ncontact Surgical, Inc. | 2008 | — |
| +1 | K090202 | Numeris Guided Coagulation System with Visitrax, Models CSK-121, -122, -123… | Ncontact Surgical, Inc. | 2009 | — |
| +2 | K120857 | Epi-Sense Guided Coagulation Device with Visitrax | Ncontact Surgical, Inc. | 2012 | — |
| +3 | K142084 | Epi-Sense Guided Coagulation Device with Visitrax | Ncontact Surgical, Inc. | 2014 | 1 |
| +4 | K193162 | EPi-Sense Guided Coagulation System with VisiTrax | AtriCure, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 2001 | 4 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K063012 | Ncontact Coagulation System Kit, Model CSKSummary page 1…(CSK) Model numbers: CSK-100; CSK-200; CSK-500 Legally marketed unmodified K063012 cleared Dec. 1/06 device 510k number K071819 cleared July 26/07 (will be… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090202 | Numeris Guided Coagulation System with Visitrax, Models CSK-121, -122, -123 and -125 | 2009 | 3 |
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 16 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K090202 (Ncontact Surgical, Inc., 2009) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K063012.
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 NumerisTM Tethered Coagulation System with VisiTrax® is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy during open-chest cardiac surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082203 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082203: Numeris Coagulation System with Visitrax, Model (S) CSK-021;CSK-022; CSK-023; CSK-025.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082203
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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