510(k) · Cleared
ClearedUnipolar Pediatric Temporary Pacing Lead, Unipolar Temporary Atrial Pacing Lead, Unipolar Temporary Myocardial Pacing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · LDF Electrode, Pacemaker, Temporary
Cleared on Jun 6, 2014 as substantially equivalent to K012454 (Medtronic Vascular, 2001) and 4 other predicates after a 51-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Jun 6, 2014
- Review
- 51 days
- Class
- Class II
- Product code
- LDF
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K012454 (2001). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK012454 Model 6491 Unipolar Pediatric Temporary Pacing LeadMedtronic Vascular · 2001
- This deviceK140972 Unipolar Pediatric Temporary Pacing Lead, Unipolar Temporary Atrial…Medtronic, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK171253 Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline…Medtronic · 2017
- Descendant · cites it directly · 1 of its ownK190716 Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline…Medtronic · 2019
- Descendant · 2 generations on · 0 of its ownK242705 Streamline Unipolar Pediatric Temporary Pacing Lead (6491)…Medtronic, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K171253Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar…Medtronic · 2017 · cites it directly2descendants
- K190716Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar…Medtronic · 2019 · cites it directly1descendant
- K242705Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary…Medtronic, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012454 | Model 6491 Unipolar Pediatric Temporary Pacing Lead | Medtronic Vascular | 2001 | — |
| 0 (this device) | K140972 | Unipolar Pediatric Temporary Pacing Lead, Unipolar Temporary Atrial Pacing… | Medtronic, Inc. | 2014 | — |
| +1 | K171253 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492… | Medtronic | 2017 | — |
| +1 | K190716 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492… | Medtronic | 2019 | — |
| +2 | K242705 | Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar… | Medtronic, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 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? (5)
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 |
|---|---|---|---|
| * | K012454 | Model 6491 Unipolar Pediatric Temporary Pacing LeadSummary page 2…K140972 51 0(k) Summary Page 2 of 3 Predicate Devices Model Product Name K012454 6491 Unipolar Pediatric Temporary Pacing Lead K012458 6492 U… | 2001 |
| * | K012458 | Model 6492 Unipolar Temporary Atrial Pacing LeadSummary page 2…Predicate Devices Model Product Name K012454 6491 Unipolar Pediatric Temporary Pacing Lead K012458 6492 Unipolar Temporary Atrial Pacing Lead K(012459 6494 Unip… | 2001 |
| * | K012459 | Model 6494 Unipolar Temporary Myocardial Pacing WireSummary page 2…6491 Unipolar Pediatric Temporary Pacing Lead K012458 6492 Unipolar Temporary Atrial Pacing Lead K(012459 6494 Unipolar Temporary Myocardial Pacing Wire K012460 6495 B… | 2001 |
| * | K012460 | Model 6495 Bipolar Temporary Myocardial Pacing LeadSummary page 2…6492 Unipolar Temporary Atrial Pacing Lead K(012459 6494 Unipolar Temporary Myocardial Pacing Wire K012460 6495 Bipolar Temporary Myocardial Pacing Lead K012452 6500 U… | 2001 |
| * | K012452 | Model 6500 Unipolar Temorary Myocardial Pacing LeadSummary page 2…6494 Unipolar Temporary Myocardial Pacing Wire K012460 6495 Bipolar Temporary Myocardial Pacing Lead K012452 6500 Unipolar Temporary Myocardial Pacing Lead III. Indications for Use and Device Descript… | 2001 |
What descends from it? (3)
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?
- None of the 5 ancestors has a recall.
- Of its descendants, K171253 (Medtronic, 2017) has gone furthest, with 2 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. 2014, this device’s year, is highlighted.
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 6491 Unipolar Pediatric Temporary Pacing Lead 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. The Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for temporary atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single…
Read the full statement (190 words)
The Model 6491 Unipolar Pediatric Temporary Pacing Lead 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.
The Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for temporary atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.
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.
The Model 6495 Bipolar Temporary Myocardial Pacing Lead 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.
The Model 6500 Unipolar Temporary Myocardial Pacing Lead is designed for temporary 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 as stated in the FDA summary.
https://510kreport.com/device/K140972 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140972: Unipolar Pediatric Temporary Pacing Lead, Unipolar Temporary Atrial Pacing Lead, Unipolar Temporary Myocardial Pacing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140972
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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