510(k) · Cleared
ClearedSteelex Electrode Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · LDF Electrode, Pacemaker, Temporary
Cleared on Apr 22, 2003 as substantially equivalent to K980503 (ETHICON, Inc., 1998) and 1 other predicate after a 60-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Apr 22, 2003
- Review
- 60 days
- Class
- Class II
- Product code
- LDF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K980503 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK980503 Temporary Cardiac Pacing WireETHICON, Inc. · 1998
- This deviceK030556 Steelex Electrode SetAesculap, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980503 | Temporary Cardiac Pacing Wire | ETHICON, Inc. | 1998 | — |
| 0 (this device) | K030556 | Steelex Electrode Set | Aesculap, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K980503 | Temporary Cardiac Pacing WireSummary page 1…devices. SUBSTANTIAL EQUIVALENCE Aesculap@,Inc. believes that the Steelex Electrode Set is substantially equivalent to: Ethicon, Inc.; Temporary Cardiac Pacing Wire (K980503) Medtronic; Model 6494 Unipolar Temporary Myocardial pacing Wire (KO12459) DEPARTMENT OF HEALTH & HUMAN… | 1998 |
| * | K012459 | Model 6494 Unipolar Temporary Myocardial Pacing Wire | 2001 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K980503.
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 Steelex Electrode Set is intended for use in temporary cardiac pacing or monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030556 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030556: Steelex Electrode Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030556
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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