510(k) · Cleared
Recalled · Class II · 2013Atricure Isolator Transpolar Pen
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 Jun 13, 2005 as substantially equivalent to K013392 (Medtronic Vascular, 2002) and 2 other predicates after a 110-day review. Its family tree reaches back 6 generations to 1995. 18 later devices descend from it. It has been recalled once.
- Decided
- Jun 13, 2005
- Review
- 110 days
- Class
- Class II
- Product code
- OCL
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 6 generations to K942299 (1995). 39 ancestors in all, the oldest K811390 (1981). 18 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 5 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 4 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 3 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 2 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 1 generation backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- This deviceK050459 Atricure Isolator Transpolar PenAtriCure, Inc. · 2005
- Descendant · cites it directly · 13 of its ownK073605 Atricure Coolrail Linear PenAtriCure, Inc. · 2008
- Descendant · cites it directly · 13 of its ownK061593 Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and…AtriCure, Inc. · 2006 · Recalled
- 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
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K073605Atricure Coolrail Linear PenAtriCure, Inc. · 2008 · cites it directly13descendants
- K061593Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1AtriCure, Inc. · 2006 · cites it directly13descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −5 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −4 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −3 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −2 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −1 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| 0 (this device) | K050459 | Atricure Isolator Transpolar Pen | AtriCure, Inc. | 2005 | — |
| +1 | K073605 | Atricure Coolrail Linear Pen | AtriCure, Inc. | 2008 | — |
| +1 | K061593 | Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1 | AtriCure, Inc. | 2006 | 1 |
| +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 | — |
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 | 7 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 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? (3)
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 |
|---|---|---|---|
| * | K013392 | Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation…Summary page 1…uring cardiac surgery using radiofrequency energy. Predicate Devices The predicate device for the Isolator Transpolar Pen are the Medtronic Cardioblate Pen (K01 3392), the Tissue Link Bipolar Sealer 2.3 (Bipolar Floating Ball) device (K032132) and the AtriCure Bipolar System (K02091 9).… | 2002 |
| * | K032132 | Tissuelink Floating Ball Model 23-201-1Summary page 1…icate device for the Isolator Transpolar Pen are the Medtronic Cardioblate Pen (K01 3392), the Tissue Link Bipolar Sealer 2.3 (Bipolar Floating Ball) device (K032132) and the AtriCure Bipolar System (K02091 9). Device Description The Isolator Transpolar pen is a sterile, single use, elec… | 2003 |
| * | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1Summary page 1…en are the Medtronic Cardioblate Pen (K01 3392), the Tissue Link Bipolar Sealer 2.3 (Bipolar Floating Ball) device (K032132) and the AtriCure Bipolar System (K02091 9). Device Description The Isolator Transpolar pen is a sterile, single use, electrosurgery device to be used in conju… | 2002 |
What descends from it? (18)
See all 183 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 10 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 39 ancestors have a recall of any class.
- Of its descendants, K073605 (AtriCure, Inc., 2008) has gone furthest, with 13 descendants of its own.
- 11 other devices also cite its predicate K013392.
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 Isolator Tm Transpolar Tm pen is a device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050459: Atricure Isolator Transpolar Pen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050459
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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