510(k) · Cleared
ClearedStreamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic · LDF Electrode, Pacemaker, Temporary
Cleared on Aug 8, 2019 as substantially equivalent to K171253 (Medtronic, 2017) and 1 other predicate after a 142-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Aug 8, 2019
- Review
- 142 days
- Class
- Class II
- Product code
- LDF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K012454 (2001). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK012454 Model 6491 Unipolar Pediatric Temporary Pacing LeadMedtronic Vascular · 2001
- 2 generations backK140972 Unipolar Pediatric Temporary Pacing Lead, Unipolar Temporary Atrial…Medtronic, Inc. · 2014
- 1 generation backK171253 Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline…Medtronic · 2017
- This deviceK190716 Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline…Medtronic · 2019
- Descendant · cites it directly · 0 of its ownK242705 Streamline Unipolar Pediatric Temporary Pacing Lead (6491)…Medtronic, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K242705Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary…Medtronic, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K012454 | Model 6491 Unipolar Pediatric Temporary Pacing Lead | Medtronic Vascular | 2001 | — |
| −2 | 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 | — |
| 0 (this device) | K190716 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492… | Medtronic | 2019 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K171253 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar…Summary page 4…oduct Classification: Class II Product Code: LDF Predicate Devices Model Product Name K171253 6491 Unipolar Pediatric Temporary Pacing Lead K171253 649… | 2017 |
| * | K140972 | Unipolar Pediatric Temporary Pacing Lead, Unipolar Temporary Atrial Pacing Lead…Summary page 4…6491 Unipolar Pediatric Temporary Pacing Lead K171253 6492 Unipolar Temporary Atrial Pacing Lead K140972 6494 Unipolar Temporary Myocardial Pacing Wire K171253 64… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242705 | Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary… | 2025 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K242705 (Medtronic, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K171253.
How does its category compare?
All LDF devicesLDF Electrode, Pacemaker, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 intended for temporary postsurgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY. The Model 6492 Unipolar Temporary Atrial Pacing Lead is intended for temporary postsurgical atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied…
Read the full statement (162 words)
The Model 6491 Unipolar Pediatric Temporary Pacing Lead is intended for temporary postsurgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.
The Model 6492 Unipolar Temporary Atrial Pacing Lead is intended for temporary postsurgical atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY
The Model 6494 Unipolar Temporary Myocardial Pacing wire is intended for temporary postsurgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.
The Model 6495 Bipolar Temporary Myocardial Pacing Lead is intended for temporary postsurgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190716: Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190716
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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