510(k) · Cleared
ClearedTempo Temporary Pacing Lead
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotrace Medical, Inc. · LDF Electrode, Pacemaker, Temporary
Cleared on Oct 25, 2016 as substantially equivalent to K042190 (Medtronic Vascular, 2004) after a 267-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.
- Decided
- Oct 25, 2016
- Review
- 267 days
- Class
- Class II
- Product code
- LDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042190 (2004). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K252042Sync AV II Temporary Pacing CatheterSwift Sync, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042190 | Model 6416 Temporary Pacing Lead System | Medtronic Vascular | 2004 | 1 |
| 0 (this device) | K160260 | Tempo Temporary Pacing Lead | Biotrace Medical, Inc. | 2016 | — |
| +1 | K252042 | Sync AV II Temporary Pacing Catheter | Swift Sync, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K042190 | Model 6416 Temporary Pacing Lead SystemSummary page 5…nitoring device. Predicate Device: BioTrace Medical cites the following as predicate and reference devices. Predicate Device Medtronic Temporary K042190 Transvenous Pacing Lead System (Model 6416) Reference Devices C.R.… | 2004 |
| † | K800298 | Usci Bipolar Ballon Pacing Electrode | 1980 |
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 |
|---|---|---|---|
| K252042 | Sync AV II Temporary Pacing Catheter | 2026 | 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?
- Its one ancestor has a recall.
- Of its descendants, K252042 (Swift Sync, Inc., 2026) has gone furthest, with 0 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. 2016, 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 BioTrace Medical Tempo Temporary Pacing Lead is indicated for use in temporary intracardiac pacing for a maximum of seven (7) days and is designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160260 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160260: Tempo Temporary Pacing Lead.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160260
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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