510(k) · Cleared
ClearedUsci Bipolar Ballon Pacing Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · LDF Electrode, Pacemaker, Temporary
Cleared on Apr 16, 1980 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Apr 16, 1980
- Review
- 65 days
- Class
- Class II
- Product code
- LDF
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK800298 Usci Bipolar Ballon Pacing ElectrodeC.R. Bard, Inc. · 1980
- Descendant · cites it directly · 6 of its ownK192454 Wattson Temporary Pacing GuidewireVascular Solutions · 2020
- Descendant · 2 generations on · 4 of its ownK213854 SavvyWireOpsens, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK955712 Usci Bipolar Balloon Pacing Electrode with BH CoatingC.R. Bard, Inc. · 1996
- Descendant · 3 generations on · 1 of its ownK241418 OptoMonitor 3Opsens, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK241334 Semi-Floating Temporary Pacing Electrode Catheter, Bipolar…C.R. Bard, Inc. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K192454Wattson Temporary Pacing GuidewireVascular Solutions · 2020 · cites it directly6descendants
- K213854SavvyWireOpsens, Inc. · 2022 · 2 generations on4descendants
- K955712Usci Bipolar Balloon Pacing Electrode with BH CoatingC.R. Bard, Inc. · 1996 · cites it directly2descendants
- K241418OptoMonitor 3Opsens, Inc. · 2025 · 3 generations on1descendant
- K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes…C.R. Bard, Inc. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K800298 | Usci Bipolar Ballon Pacing Electrode | C.R. Bard, Inc. | 1980 | — |
| +1 | K192454 | Wattson Temporary Pacing Guidewire | Vascular Solutions | 2020 | — |
| +2 | K213854 | SavvyWire | Opsens, Inc. | 2022 | — |
| +1 | K955712 | Usci Bipolar Balloon Pacing Electrode with BH Coating | C.R. Bard, Inc. | 1996 | — |
| +3 | K241418 | OptoMonitor 3 | Opsens, Inc. | 2025 | — |
| +2 | K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel… | C.R. Bard, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
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?
- Of its descendants, K192454 (Vascular Solutions, 2020) has gone furthest, with 6 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.
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) | — |
https://510kreport.com/device/K800298 · printed Nov 4, 2026
Cite this page
510(k) Report. “K800298: Usci Bipolar Ballon Pacing Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K800298
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026