510(k) · Cleared
ClearedCoolrail Linear Pen Model Mcri
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 Sep 26, 2012 as substantially equivalent to K073605 (AtriCure, Inc., 2008) after a 30-day review. Its family tree reaches back 8 generations to 1995. 3 later devices descend from it.
- Decided
- Sep 26, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- OCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K942299 (1995). 41 ancestors in all, the oldest K811390 (1981). 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 7 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 6 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 5 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 4 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 3 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 2 generations backK050459 Atricure Isolator Transpolar PenAtriCure, Inc. · 2005 · Recalled
- 1 generation backK073605 Atricure Coolrail Linear PenAtriCure, Inc. · 2008
- This deviceK122611 Coolrail Linear Pen Model McriAtriCure, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK183065 Coolrail Linear PenAtriCure, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK190587 Coolrail Linear PenAtriCure, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK221358 Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5)…AtriCure, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See all- K183065Coolrail Linear PenAtriCure, Inc. · 2018 · cites it directly2descendants
- K190587Coolrail Linear PenAtriCure, Inc. · 2019 · 2 generations on1descendant
- K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −7 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −6 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −5 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −4 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −3 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −2 | K050459 | Atricure Isolator Transpolar Pen | AtriCure, Inc. | 2005 | 1 |
| −1 | K073605 | Atricure Coolrail Linear Pen | AtriCure, Inc. | 2008 | — |
| 0 (this device) | K122611 | Coolrail Linear Pen Model Mcri | AtriCure, Inc. | 2012 | — |
| +1 | K183065 | Coolrail Linear Pen | AtriCure, Inc. | 2018 | — |
| +2 | K190587 | Coolrail Linear Pen | AtriCure, Inc. | 2019 | — |
| +3 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K073605 | Atricure Coolrail Linear PenSummary page 1…ring cardiac surgery using radiofireguency energy. Cleared Device The device proposed for modification in this submission is the Coolrail Linear Pen cleared via 51 0(k) K073605 on March 11, 2008. Device Description The Coolrail Linear Pen is a sterile; single use, electrosurgery device to be used in conj… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183065 | Coolrail Linear Pen | 2018 | 2 |
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 17 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 41 ancestors have a recall of any class.
- Of its descendants, K183065 (AtriCure, Inc., 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K073605.
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. 2012, 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 energy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122611: Coolrail Linear Pen Model Mcri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122611
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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