510(k) · Cleared
ClearedModel 6494 Unipolar Temporary Myocardial Pacing Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · LDF Electrode, Pacemaker, Temporary
Cleared on Aug 14, 2001 after a 13-day review. The FDA summary names its predicate without a number. 26 later devices descend from it.
- Decided
- Aug 14, 2001
- Review
- 13 days
- Class
- Class II
- Product code
- LDF
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 3 citing it directly.
- This deviceK012459 Model 6494 Unipolar Temporary Myocardial Pacing WireMedtronic Vascular · 2001
- Descendant · cites it directly · 20 of its ownK040812 Detect Surgical Pacing and Mapping ToolMedtronic Vascular · 2004
- Descendant · 2 generations on · 19 of its ownK051749 Cobra Surgical SystemEstech, Inc. · 2005
- Descendant · 2 generations on · 13 of its ownK061593 Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and…AtriCure, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 9 of its ownK100501 Multifunctional Linear PenAtriCure, Inc. · 2010
- Descendant · 3 generations on · 4 of its ownK113475 Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech · 2012 · Recalled
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K040812Detect Surgical Pacing and Mapping ToolMedtronic Vascular · 2004 · cites it directly20descendants
- K051749Cobra Surgical SystemEstech, Inc. · 2005 · 2 generations on19descendants
- K061593Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1AtriCure, Inc. · 2006 · 2 generations on13descendants
- K100501Multifunctional Linear PenAtriCure, Inc. · 2010 · 3 generations on9descendants
- K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech · 2012 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012459 | Model 6494 Unipolar Temporary Myocardial Pacing Wire | Medtronic Vascular | 2001 | — |
| +1 | K040812 | Detect Surgical Pacing and Mapping Tool | Medtronic Vascular | 2004 | — |
| +2 | K051749 | Cobra Surgical System | Estech, Inc. | 2005 | — |
| +2 | K061593 | Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1 | AtriCure, Inc. | 2006 | 1 |
| +3 | K100501 | Multifunctional Linear Pen | AtriCure, Inc. | 2010 | — |
| +3 | K113475 | Estech Cobra Adhere XL 2 Surgical System | Endoscopic Technologies, Inc. D/B/A Estech | 2012 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 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 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2019 | 4 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 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
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 |
|---|---|---|---|
| * | — | Model 6494 Unipolar Temporary Myocardial Pacing Wire Named without a submission number |
What descends from it? (26)
See all 263 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?
- Of its descendants, K040812 (Medtronic Vascular, 2004) has gone furthest, with 20 descendants of its own.
How does its category compare?
All LDF devicesLDF Electrode, Pacemaker, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDF
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LDF
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDF
1in 2018
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LDF
139in 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 Model 6494 Unipolar Temporary Myocardial Pacing Wire is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012459 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012459: Model 6494 Unipolar Temporary Myocardial Pacing Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012459
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026