510(k) · Cleared

Cleared

Detect Surgical Pacing and Mapping Tool

K040812510(k) TraditionalCleared Sep 2, 2004157-day reviewClass II21 CFR 870.3680

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

Medtronic Vascular · LDF Electrode, Pacemaker, Temporary

Cleared on Sep 2, 2004 as substantially equivalent to K012459 (Medtronic Vascular, 2001) after a 157-day review. Its family tree reaches back 1 generation to 2001. 20 later devices descend from it.

Decided: Sep 2, 2004
Review: 157 days
Class: Class II
Product code: LDF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K012459 (2001). 20 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK012459 Model 6494 Unipolar Temporary Myocardial Pacing WireMedtronic Vascular · 2001
This deviceK040812 Detect Surgical Pacing and Mapping ToolMedtronic Vascular · 2004
Descendant · cites it directly · 19 of its ownK051749 Cobra Surgical SystemEstech, Inc. · 2005
Descendant · cites it directly · 13 of its ownK061593 Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and…AtriCure, Inc. · 2006 · Recalled
Descendant · 2 generations on · 9 of its ownK100501 Multifunctional Linear PenAtriCure, Inc. · 2010
Descendant · 2 generations on · 4 of its ownK113475 Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech · 2012 · Recalled
Descendant · 3 generations on · 3 of its ownK130521 Isolator Linear PenAtriCure, Inc. · 2013

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2005high 3 (2012) · low 0 (2008)2026

Most influential descendants

Showing 5 of 20 · See all

K051749Cobra Surgical SystemEstech, Inc. · 2005 · cites it directly19descendants
K061593Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1AtriCure, Inc. · 2006 · cites it directly13descendants
K100501Multifunctional Linear PenAtriCure, Inc. · 2010 · 2 generations on9descendants
K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech · 2012 · 2 generations on4descendants
K130521Isolator Linear PenAtriCure, Inc. · 2013 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K012459	Model 6494 Unipolar Temporary Myocardial Pacing Wire	Medtronic Vascular	2001	—
0 (this device)	K040812	Detect Surgical Pacing and Mapping Tool	Medtronic Vascular	2004	—
+1	K051749	Cobra Surgical System	Estech, Inc.	2005	—
+1	K061593	Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1	AtriCure, Inc.	2006	1
+2	K100501	Multifunctional Linear Pen	AtriCure, Inc.	2010	—
+2	K113475	Estech Cobra Adhere XL 2 Surgical System	Endoscopic Technologies, Inc. D/B/A Estech	2012	5
+3	K130521	Isolator Linear Pen	AtriCure, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	2	0
2007	1	0
2009	1	0
2010	1	0
2011	1	0
2012	3	0
2013	1	0
2014	1	0
2015	1	0
2017	3	0
2019	3	0
2022	1	0

FIG. 1 — Lineage of K040812, 2001–2022Source: 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 LDF? 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 LDF device

#1 K241334 Semi-Floating Temporary Pacing Electrode…score 12.1 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	K012459	Model 6494 Unipolar Temporary Myocardial Pacing Wire Summary page 1 …80 Product Code: LDF Predicate Device: StreamlineTM 6494 Unipolar Temporary Myocardial Pacing Wire 510(k) No. K012459, Reg. No. 870.3680; Product Code: LDF Device Intended Use: The Model 6494 Unipolar Temporary…	Medtronic Vascular	2001	—

Also cleared against K012459: 2 other devices →

What descends from it? (20)

See all 20

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K051749	Cobra Surgical System	Estech, Inc.	2005	19
K061593	Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1	AtriCure, Inc.	2006	13
K070288	Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814	Medtronic Vascular	2007	2
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?

Its one ancestor has no recall.
Of its descendants, K051749 (Estech, Inc., 2005) has gone furthest, with 19 descendants of its own.
2 other devices also cite its predicate K012459.

How does its category compare?

All LDF devices

LDF Electrode, Pacemaker, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LDF

5in 2025

2007high 5 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LDF

266in 2025

2007high 266 (2025) · low 138 (2016)2026

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

Recalls per year · LDF

1in 2018

2007high 2 (2008) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LDF

139in 2025

2007high 212 (2023) · low 18 (2008)2025

MAUDE reports naming product code LDF, 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	0	—	0	25
2008	1	—	2	18
2009	0	—	2	44
2010	0	—	0	48
2011	0	—	1	35
2012	0	—	1	68
2013	0	—	0	74
2014	1	—	0	68
2015	2	—	0	81
2016	3	138	0	90
2017	1	—	0	79
2018	1	—	1 (1)	91
2019	1	—	0	130
2020	0	—	0	83
2021	0	—	0	125
2022	0	—	0	117
2023	0	—	0	212
2024	1	—	0	190
2025	5	266	0	139
2026	1	—	1 (1)	—

What is it indicated for?

The DETECT TM Surgical Pacing and Mapping Tool is a handheld, single use device designed to provide temporary cardiac pacing or monitoring.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040812 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040812: Detect Surgical Pacing and Mapping Tool.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040812

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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