510(k) · Cleared
ClearedUsci Bipolar Balloon Pacing Electrode with BH Coating
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 Oct 11, 1996 as substantially equivalent to K800298 (C.R. Bard, Inc., 1980) after a 301-day review. Its family tree reaches back 1 generation to 1980. 2 later devices descend from it.
- Decided
- Oct 11, 1996
- Review
- 301 days
- Class
- Class II
- Product code
- LDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K800298 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK800298 Usci Bipolar Ballon Pacing ElectrodeC.R. Bard, Inc. · 1980
- This deviceK955712 Usci Bipolar Balloon Pacing Electrode with BH CoatingC.R. Bard, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK241334 Semi-Floating Temporary Pacing Electrode Catheter, Bipolar…C.R. Bard, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK251186 Bard® Temporary Pacing Electrode Catheter Needle / Cannula…C.R. Bard, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K800298 | Usci Bipolar Ballon Pacing Electrode | C.R. Bard, Inc. | 1980 | — |
| 0 (this device) | K955712 | Usci Bipolar Balloon Pacing Electrode with BH Coating | C.R. Bard, Inc. | 1996 | — |
| +1 | K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel… | C.R. Bard, Inc. | 2025 | — |
| +2 | K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | C.R. Bard, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K800298 | Usci Bipolar Ballon Pacing ElectrodeSummary page 3…ectrode. 6.2 The coated USCI Bipolar Pacing Electrode is substantially equivalent to the uncoated USCI® Bipolar Balloon Pacing Electrode (covered under #K800298). The similarities between the current devices, the USCI Bipolar Pacing Electrodes and the predicate device, the USCI® Bipolar B… | 1980 |
| † | K791873 | Usci Safe-T-Cloth Thermodilution Cat. | 1979 |
| † | K830094 | Usci Temp. Atrio-Ventricular Electrode | 1983 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes… | 2025 | 1 |
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?
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) | — |
What is it indicated for?
The USCI® Balloon Bipolar Pacing Electrodes and the USCI® Special Care Electrodes (temporary pacing leads) are used to transmit an electrical stimulus from the pulse generator to the heart and/or to transmit an electrical signal from the heart to a recording device. These devices are sold sterile and are for one time use only. In addition to the pacing electrode with BH coating, each catheter is packaged with a needle cannula, an EKG clip, and a syringe to assist in the use of the pacing electrode.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K955712 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955712: Usci Bipolar Balloon Pacing Electrode with BH Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955712
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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