510(k) · Cleared
ClearedIsolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)
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 Dec 30, 2022 as substantially equivalent to K192125 (AtriCure, Inc., 2019) and 4 other predicates after a 233-day review. Its family tree reaches back 12 generations to 1995.
- Decided
- Dec 30, 2022
- Review
- 233 days
- Class
- Class II
- Product code
- OCL
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K942299 (1995). 78 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.
- Root · 12 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 8 generations between
- 3 generations backK130521 Isolator Linear PenAtriCure, Inc. · 2013
- 2 generations backK163408 Isolator Multifunctional Linear PenAtriCure, Inc. · 2017
- 1 generation backK192125 Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc. · 2019
- This deviceK221358 Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5)…AtriCure, Inc. · 2022
Show all 12 generations
- Root · 12 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 11 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 10 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 9 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 8 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 7 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 6 generations backK050459 Atricure Isolator Transpolar PenAtriCure, Inc. · 2005 · Recalled
- 5 generations backK061593 Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and…AtriCure, Inc. · 2006 · Recalled
- 4 generations backK100501 Multifunctional Linear PenAtriCure, Inc. · 2010
- 3 generations backK130521 Isolator Linear PenAtriCure, Inc. · 2013
- 2 generations backK163408 Isolator Multifunctional Linear PenAtriCure, Inc. · 2017
- 1 generation backK192125 Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc. · 2019
- This deviceK221358 Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5)…AtriCure, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −11 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −10 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −9 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −8 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −7 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −6 | K050459 | Atricure Isolator Transpolar Pen | AtriCure, Inc. | 2005 | 1 |
| −5 | K061593 | Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1 | AtriCure, Inc. | 2006 | 1 |
| −4 | K100501 | Multifunctional Linear Pen | AtriCure, Inc. | 2010 | — |
| −3 | K130521 | Isolator Linear Pen | AtriCure, Inc. | 2013 | — |
| −2 | K163408 | Isolator Multifunctional Linear Pen | AtriCure, Inc. | 2017 | — |
| −1 | K192125 | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen | AtriCure, Inc. | 2019 | — |
| 0 (this device) | 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 |
| 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 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K192125 | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenSummary page 9…Product Code: OCL Classification Panel: Cardiovascular Predicate Devices: • Isolator® Linear Pen (MLP1) cleared via K192125 on November 4, 2019 • Isolator® Transpolar Pen (MAX1, MAX5) cleared via K192125 on… | 2019 |
| * | K190587 | Coolrail Linear PenSummary page 9…• Isolator® Transpolar Pen (MAX1, MAX5) cleared via K192125 on November 4, 2019 • Coolrail® Linear Pen (MCR1) cleared via K190587 on July 24, 2019 • Isolator® Synergy Surgical Ablation System (EMR2, EML2) cleared vi… | 2019 |
| * | K211311 | AtriCure Isolator® Synergy™ Surgical Ablation SystemSummary page 9…Linear Pen (MCR1) cleared via K190587 on July 24, 2019 • Isolator® Synergy Surgical Ablation System (EMR2, EML2) cleared via K211311 on May 28, 2021 • Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System clear… | 2021 |
| * | K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDESummary page 9…via K211311 on May 28, 2021 • Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System cleared via K210477 on July 26, 2021 • Isolator® Synergy Access Clamp (EMT1) cleared via K110117 on April… | 2021 |
| * | K110117 | Atricure Bipolar SystemSummary page 9…ss Clamp (OLH, OSH) and Guide System cleared via K210477 on July 26, 2021 • Isolator® Synergy Access Clamp (EMT1) cleared via K110117 on April 8, 2011. 510(k) Summary K221358 Page 1… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 78 ancestors have a recall of any class.
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. 2022, 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 linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU/ASB or MAG 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…
Read the full statement (191 words)
The Isolator linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU/ASB or MAG 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.
The Isolator Transpolar Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy.
The Isolator Transpolar 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.
The Coolrail® linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy.
The AtriCure Bipolar (Transpolar) System is intended to ablate cardiac tissue during surgery.
The AtriCure Isolator Synergy EnCompass Clamp and Guide system is intended to ablate cardiac tissue during surgery.
The AtriCure Bipolar (Transpolar) System is intended to ablate cardiac tissue during surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221358: Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221358
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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