510(k) · Cleared

Cleared

Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814

K070288510(k) TraditionalCleared Jun 18, 2007139-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Vascular · OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Cleared on Jun 18, 2007 as substantially equivalent to K040812 (Medtronic Vascular, 2004) and 3 other predicates after a 139-day review. Its family tree reaches back 8 generations to 1995. 2 later devices descend from it.

Decided: Jun 18, 2007
Review: 139 days
Class: Class II
Product code: OCL
Recalls: None
Predicates: 4

Its longest line of descent runs back 8 generations to K942299 (1995). 48 ancestors in all, the oldest K811390 (1981). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

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 deviceK070288 Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814Medtronic Vascular · 2007
Descendant · cites it directly · 1 of its ownK090721 Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing…Medtronic · 2009
Descendant · 2 generations on · 0 of its ownK121451 Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing…Medtronic, Inc. · 2012

Most influential descendants

Showing 2 of 2 · See all

K090721Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205Medtronic · 2009 · cites it directly1descendant
K121451Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing DeviceMedtronic, Inc. · 2012 · 2 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	K061593	Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1	AtriCure, Inc.	2006	1
0 (this device)	K070288	Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814	Medtronic Vascular	2007	—
+1	K090721	Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model…	Medtronic	2009	—
+2	K121451	Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing Device	Medtronic, Inc.	2012	—

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	2	0
2004	2	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2012	1	0

FIG. 1 — Lineage of K070288, 1995–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K040812	Detect Surgical Pacing and Mapping Tool Summary page 2 …hat have active endocarditis at the time of surgery. Predicate Device 1: Medtronic DetectTM Surgical Pacing and Mapping Tool 510(k) No. K040812, Reg. No. 870.3680; Product Code: LDF Predicate Device Intended Use: The Medtronic DetectTM Surgical…	Medtronic Vascular	2004	—
*	K061593	Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1 Summary page 2 …designed to provide temporary cardiac pacing or monitoring. Predicate Device 2: Atricure IsolatorTM Transpolar Pen System 510(k) No. K061593, Reg. No. 878.4400; Product Code: GEL Predicate Device Intended Use: The IsolatorTM Transpolar Pen is…	AtriCure, Inc.	2006	1
*	K013392	Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation… Summary page 1 …ion System, which consists of the Cardioblate® Surgical Ablation Generator (K060400) and Monopolar Pen (K013392 and K031247) Classification Name: Electrosurgical, Cutting & Coagulation & Accessories Classification: Class I…	Medtronic Vascular	2002	1
*	K031247	Cardioblate Bipolar Radiofrequency Surgical Ablation System Summary page 1 …which consists of the Cardioblate® Surgical Ablation Generator (K060400) and Monopolar Pen (K013392 and K031247) Classification Name: Electrosurgical, Cutting & Coagulation & Accessories Classification: Class II, 21 CFR 87…	Medtronic Vascular	2003	—

Also cleared against K040812: 3 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K090721	Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205	Medtronic	2009	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 12 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
4 of the 48 ancestors have a recall of any class.
Of its descendants, K090721 (Medtronic, 2009) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K040812.

How does its category compare?

All OCL devices

OCL 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. 2007, this device’s year, is highlighted.

FDA decisions per year · OCL

1in 2025

2007high 6 (2012) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCL

85in 2019

2007high 139 (2007) · low 75 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OCL

1in 2021

2007high 4 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OCL

46in 2025

2007high 99 (2023) · low 0 (2007)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 Cardioblate® Monopolar Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue using radiofrequency energy when connected to the Cardioblate®generator or for temporary cardiac pacing, sensing, recording and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070288 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070288: Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070288

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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