510(k) · Cleared
Recalled · Class II · 2013Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1
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 Jul 12, 2006 as substantially equivalent to K050459 (AtriCure, Inc., 2005) and 3 other predicates after a 34-day review. Its family tree reaches back 7 generations to 1995. 13 later devices descend from it. It has been recalled once.
- Decided
- Jul 12, 2006
- Review
- 34 days
- Class
- Class II
- Product code
- OCL
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 7 generations to K942299 (1995). 46 ancestors in all, the oldest K811390 (1981). 13 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 backK050459 Atricure Isolator Transpolar PenAtriCure, Inc. · 2005 · Recalled
- This deviceK061593 Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and…AtriCure, Inc. · 2006
- Descendant · cites it directly · 9 of its ownK100501 Multifunctional Linear PenAtriCure, Inc. · 2010
- Descendant · 2 generations on · 4 of its ownK113475 Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech · 2012 · Recalled
- Descendant · 2 generations on · 3 of its ownK130521 Isolator Linear PenAtriCure, Inc. · 2013
- Descendant · 3 generations on · 2 of its ownK163408 Isolator Multifunctional Linear PenAtriCure, Inc. · 2017
- Descendant · 3 generations on · 2 of its ownK120857 Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K100501Multifunctional Linear PenAtriCure, Inc. · 2010 · cites it directly9descendants
- K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech · 2012 · 2 generations on4descendants
- K130521Isolator Linear PenAtriCure, Inc. · 2013 · 2 generations on3descendants
- K163408Isolator Multifunctional Linear PenAtriCure, Inc. · 2017 · 3 generations on2descendants
- K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2012 · 3 generations on2descendants
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 | K050459 | Atricure Isolator Transpolar Pen | AtriCure, Inc. | 2005 | 1 |
| 0 (this device) | K061593 | Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1 | AtriCure, Inc. | 2006 | — |
| +1 | 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 |
| +2 | K130521 | Isolator Linear Pen | AtriCure, Inc. | 2013 | — |
| +3 | K163408 | Isolator Multifunctional Linear Pen | AtriCure, Inc. | 2017 | — |
| +3 | K120857 | Epi-Sense Guided Coagulation Device with Visitrax | Ncontact Surgical, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 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 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2022 | 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? (4)
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 |
|---|---|---|---|
| * | K050459 | Atricure Isolator Transpolar PenSummary page 1…s during surgery when connected to a temporary external cardiac pacemaker or recording device. Predicate Devices o AtriCure Isolator Transpolar Pen (K050459) o Medtronic Detect Mapping and Sensing Tool (K040812) o Viking Diagnostic Electrode Catheter (K971 265)… | 2005 |
| * | K040812 | Detect Surgical Pacing and Mapping ToolSummary page 1…pacemaker or recording device. Predicate Devices o AtriCure Isolator Transpolar Pen (K050459) o Medtronic Detect Mapping and Sensing Tool (K040812) o Viking Diagnostic Electrode Catheter (K971 265) o Estech Cobra System (K051749) Device Description… | 2004 |
| * | K971265 | Viking Diagnostic Electrode CatheterSummary page 1…o AtriCure Isolator Transpolar Pen (K050459) o Medtronic Detect Mapping and Sensing Tool (K040812) o Viking Diagnostic Electrode Catheter (K971 265) o Estech Cobra System (K051749) Device Description The Isolatorem Transpolar TM pen System (Pen) is comprise… | 1997 |
| * | K051749 | Cobra Surgical SystemSummary page 1…050459) o Medtronic Detect Mapping and Sensing Tool (K040812) o Viking Diagnostic Electrode Catheter (K971 265) o Estech Cobra System (K051749) Device Description The Isolatorem Transpolar TM pen System (Pen) is comprised of the AtriCure ® Ablation and Sensing… | 2005 |
What descends from it? (13)
See all 133 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 14, 2013 | Class II | Z-0912-2013 | Employee error | Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 46 ancestors have a recall of any class.
- Of its descendants, K100501 (AtriCure, Inc., 2010) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K050459.
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.
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 IsolatorTM TranspolarTM Pen is intended to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the Atricure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061593 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061593: Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061593
Report an extraction error
Are you the manufacturer?
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