510(k) · Cleared
ClearedMultifunctional 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 Jun 18, 2010 as substantially equivalent to K050459 (AtriCure, Inc., 2005) and 2 other predicates after a 116-day review. Its family tree reaches back 8 generations to 1995. 9 later devices descend from it.
- Decided
- Jun 18, 2010
- Review
- 116 days
- Class
- Class II
- Product code
- OCL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K942299 (1995). 48 ancestors in all, the oldest K811390 (1981). 9 later devices descend from it, 2 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 backK061593 Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and…AtriCure, Inc. · 2006 · Recalled
- This deviceK100501 Multifunctional Linear PenAtriCure, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK113475 Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech · 2012 · Recalled
- Descendant · cites it directly · 3 of its ownK130521 Isolator Linear PenAtriCure, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK163408 Isolator Multifunctional Linear PenAtriCure, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK120857 Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK192125 Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc. · 2019
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech · 2012 · cites it directly4descendants
- K130521Isolator Linear PenAtriCure, Inc. · 2013 · cites it directly3descendants
- K163408Isolator Multifunctional Linear PenAtriCure, Inc. · 2017 · 2 generations on2descendants
- K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. · 2012 · 2 generations on2descendants
- K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc. · 2019 · 3 generations on1descendant
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 | K061593 | Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1 | AtriCure, Inc. | 2006 | 1 |
| 0 (this device) | K100501 | Multifunctional Linear Pen | AtriCure, Inc. | 2010 | — |
| +1 | K113475 | Estech Cobra Adhere XL 2 Surgical System | Endoscopic Technologies, Inc. D/B/A Estech | 2012 | 5 |
| +1 | K130521 | Isolator Linear Pen | AtriCure, Inc. | 2013 | — |
| +2 | K163408 | Isolator Multifunctional Linear Pen | AtriCure, Inc. | 2017 | — |
| +2 | K120857 | Epi-Sense Guided Coagulation Device with Visitrax | Ncontact Surgical, Inc. | 2012 | — |
| +3 | K192125 | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen | AtriCure, Inc. | 2019 | — |
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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 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 |
|---|---|---|---|
| * | K050459 | Atricure Isolator Transpolar PenSummary page 1…or recording device. Predicate Devices The predicate devices for the AtriCure Multifunctional linear pen are the AtriCure Isolator Transpolar pen (K050459, K061593) and the AtriCure Coolrail linear pen (K073605). Device Description The Multifunctional linear pen is a hand-held… | 2005 |
| * | K061593 | Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1Summary page 1…r recording device. Predicate Devices The predicate devices for the AtriCure Multifunctional linear pen are the AtriCure Isolator Transpolar pen (K050459, K061593) and the AtriCure Coolrail linear pen (K073605). Device Description The Multifunctional linear pen is a hand-held, sterile… | 2006 |
| * | K073605 | Atricure Coolrail Linear PenSummary page 1…he predicate devices for the AtriCure Multifunctional linear pen are the AtriCure Isolator Transpolar pen (K050459, K061593) and the AtriCure Coolrail linear pen (K073605). Device Description The Multifunctional linear pen is a hand-held, sterile, single patient use electrosurgical ins… | 2008 |
What descends from it? (9)
2 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)
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 15 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 48 ancestors have a recall of any class.
- Of its descendants, K113475 (Endoscopic Technologies, Inc. D/B/A Estech, 2012) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K050459.
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. 2010, 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 Multifunctional 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 AtriCure Ablation and Sensing unit (ASU) or to the ASU Source Switch in Ablation mode.
The Multifunctional Linear Pen may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythniias 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/K100501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100501: Multifunctional 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/K100501
Report an extraction error
Are you the manufacturer?
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