510(k) · Cleared
ClearedPacel Bipolar Pacing Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · LDF Electrode, Pacemaker, Temporary
Cleared on Oct 22, 2015 as substantially equivalent to K875059 (Daig Corp., 1988) after a 27-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Oct 22, 2015
- Review
- 27 days
- Class
- Class II
- Product code
- LDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K875059 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK875059 Disposable Bipolar Temporary Pacing ElectrodeDaig Corp. · 1988
- This deviceK152784 Pacel Bipolar Pacing CathetersSt Jude Medical · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K875059 | Disposable Bipolar Temporary Pacing Electrode | Daig Corp. | 1988 | — |
| 0 (this device) | K152784 | Pacel Bipolar Pacing Catheters | St Jude Medical | 2015 | — |
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 |
|---|---|---|---|
| * | K875059 | Disposable Bipolar Temporary Pacing ElectrodeSummary page 4…R § 870.3680 – Cardiovascular permanent or temporary pacemaker electrode Predicate Device: Pacel™ Bipolar Pacing Catheters (K875059) Device Description: The Pacel™ Bipolar Pacing Catheters are designed to establish te… | 1988 |
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?
- Its one ancestor has no recall.
How does its category compare?
All LDF devicesLDF Electrode, Pacemaker, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 St. Jude Medical Pacel™ Bipolar Pacing Catheters are intended for use in the intracardiac pacing and/or ECG recording.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152784: Pacel Bipolar Pacing Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152784
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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