510(k) · Cleared
ClearedStreamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)
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 Jan 17, 2025 as substantially equivalent to K190716 (Medtronic, 2019) and 1 other predicate after a 130-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Jan 17, 2025
- Review
- 130 days
- Class
- Class II
- Product code
- LDF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K012454 (2001). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK012454 Model 6491 Unipolar Pediatric Temporary Pacing LeadMedtronic Vascular · 2001
- 3 generations backK140972 Unipolar Pediatric Temporary Pacing Lead, Unipolar Temporary Atrial…Medtronic, Inc. · 2014
- 2 generations backK171253 Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline…Medtronic · 2017
- 1 generation backK190716 Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline…Medtronic · 2019
- This deviceK242705 Streamline Unipolar Pediatric Temporary Pacing Lead (6491)…Medtronic, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K012454 | Model 6491 Unipolar Pediatric Temporary Pacing Lead | Medtronic Vascular | 2001 | — |
| −3 | K140972 | Unipolar Pediatric Temporary Pacing Lead, Unipolar Temporary Atrial Pacing… | Medtronic, Inc. | 2014 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K190716 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar…Summary page 5…ion Model Description Predicate 510(k) 6491 Unipolar Pediatric Temporary Pacing Lead K190716 6492 Unipolar Temporary Atrial Pacing Lead K190716 6494 Unipolar Te… | 2019 |
| * | K171253 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar…Summary page 5…K190716 6495 Bipolar Temporary Myocardial Pacing Lead K190716 6500 Unipolar Temporary Myocardial Pacing Lead K171253 Device Description Each Streamline temporary pacing lead or wire comprises a lead body with a distal and a proxim… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All LDF devicesLDF Electrode, Pacemaker, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Streamline temporary leads and wires treat an irregular heartbeat during or after cardiac surgery by providing electrical stimulation to the heart.
* Models 6491, 6494, 6495, and 6500 are intended for atrial and ventricular use.
* Model 6492 is intended for atrial use only.
* Model 6491 and Model 6492 have smaller chest fixation coils and are appropriate for use in thin heart tissue and, in the case of Model 6491, a smaller chest cavity (for example, in a pediatric patient).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242705: Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242705
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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