510(k) · Cleared
ClearedCoolrail 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 Dec 4, 2018 as substantially equivalent to K122611 (AtriCure, Inc., 2012) after a 29-day review. Its family tree reaches back 9 generations to 1995. 2 later devices descend from it.
- Decided
- Dec 4, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- OCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K942299 (1995). 42 ancestors in all, the oldest K811390 (1981). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 5 generations between
- 3 generations backK050459 Atricure Isolator Transpolar PenAtriCure, Inc. · 2005 · Recalled
- 2 generations backK073605 Atricure Coolrail Linear PenAtriCure, Inc. · 2008
- 1 generation backK122611 Coolrail Linear Pen Model McriAtriCure, Inc. · 2012
- This deviceK183065 Coolrail Linear PenAtriCure, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK190587 Coolrail Linear PenAtriCure, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK221358 Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5)…AtriCure, Inc. · 2022
Show all 9 generations
- Root · 9 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 8 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 7 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 6 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 5 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 4 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 3 generations backK050459 Atricure Isolator Transpolar PenAtriCure, Inc. · 2005 · Recalled
- 2 generations backK073605 Atricure Coolrail Linear PenAtriCure, Inc. · 2008
- 1 generation backK122611 Coolrail Linear Pen Model McriAtriCure, Inc. · 2012
- This deviceK183065 Coolrail Linear PenAtriCure, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −8 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −7 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −6 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −5 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −4 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −3 | K050459 | Atricure Isolator Transpolar Pen | AtriCure, Inc. | 2005 | 1 |
| −2 | K073605 | Atricure Coolrail Linear Pen | AtriCure, Inc. | 2008 | — |
| −1 | K122611 | Coolrail Linear Pen Model Mcri | AtriCure, Inc. | 2012 | — |
| 0 (this device) | K183065 | Coolrail Linear Pen | AtriCure, Inc. | 2018 | — |
| +1 | K190587 | Coolrail Linear Pen | AtriCure, Inc. | 2019 | — |
| +2 | 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 | 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 |
|---|---|---|
| 2019 | 1 | 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? (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 |
|---|---|---|---|
| * | K122611 | Coolrail Linear Pen Model McriSummary page 4…OCL Classification Panel: Cardiovascular Predicate Device: Coolrail linear pen (MCR1) (K122611, 26 September 2012) III. Device Description The AtriCure Coolrail Linear Pen (MCR1) is a hand held, single use surgical… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190587 | Coolrail Linear Pen | 2019 | 1 |
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 23 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 42 ancestors have a recall of any class.
- Of its descendants, K190587 (AtriCure, Inc., 2019) has gone furthest, with 1 descendant 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. 2018, 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 Coolrail linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183065 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183065: Coolrail Linear Pen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183065
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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