510(k) · Cleared
ClearedIsolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear 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 Nov 4, 2019 as substantially equivalent to K163408 (AtriCure, Inc., 2017) and 1 other predicate after a 90-day review. Its family tree reaches back 11 generations to 1995. 1 later device descends from it.
- Decided
- Nov 4, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- OCL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K942299 (1995). 51 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 backK130521 Isolator Linear PenAtriCure, Inc. · 2013
- 1 generation backK163408 Isolator Multifunctional Linear PenAtriCure, Inc. · 2017
- This deviceK192125 Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK221358 Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5)…AtriCure, Inc. · 2022
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 backK130521 Isolator Linear PenAtriCure, Inc. · 2013
- 1 generation backK163408 Isolator Multifunctional Linear PenAtriCure, Inc. · 2017
- This deviceK192125 Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc. · 2022 · 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 | K130521 | Isolator Linear Pen | AtriCure, Inc. | 2013 | — |
| −1 | K163408 | Isolator Multifunctional Linear Pen | AtriCure, Inc. | 2017 | — |
| 0 (this device) | K192125 | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen | AtriCure, Inc. | 2019 | — |
| +1 | K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail®… | AtriCure, Inc. | 2022 | — |
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 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K163408 | Isolator Multifunctional Linear PenSummary page 5…proposed for modification in this submission are the Isolator Multifunctional Linear Pen (MLP1) cleared via K163408 on January 3, 2017, and the Isolator Transpolar Pen (MAX) cleared via K061593 on July 12, 2006.… | 2017 |
| * | K061593 | Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1Summary page 5…Linear Pen (MLP1) cleared via K163408 on January 3, 2017, and the Isolator Transpolar Pen (MAX) cleared via K061593 on July 12, 2006. IV. Device Description The Isolator Multifunctional Linear Pen (MLP1) utilizes radiofrequency (RF) energy… | 2006 |
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 |
|---|---|---|---|
| K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear… | 2022 | 0 |
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 3 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 51 ancestors have a recall of any class.
- Of its descendants, K221358 (AtriCure, Inc., 2022) 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. 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 Isolator Transpolar Pen is a sterile, single use electro surgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU or to the ASU Source Switch in Ablation mode. When the Pen is connected to the ASU Source Switch in Auxiliary mode, it may be used for temporary cardiac sensing, recording, stimulation, and temporary pacing during the evaluation of cardiac arrhythmias. The…
Read the full statement (140 words)
The Isolator Transpolar Pen is a sterile, single use electro surgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU or to the ASU Source Switch in Ablation mode. When the Pen is connected to the ASU Source Switch in Auxiliary mode, it may be used for temporary cardiac sensing, recording, stimulation, and temporary pacing during the evaluation of cardiac arrhythmias.
The Isolator linear pen is a sterile, single use electro surgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU or ASB in Ablation mode.
The Isolator linear pen may be used 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/K192125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192125: Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192125
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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