# K030556: Steelex Electrode Set

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Apr 22, 2003 after 60 days
- Product code: LDF (Electrode, Pacemaker, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K980503 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980503: Temporary Cardiac Pacing Wire, ETHICON, Inc. (1998) Summary page 1.
- K012459: Model 6494 Unipolar Temporary Myocardial Pacing Wire, Medtronic Vascular (2001)

## Indications for use
The Steelex Electrode Set is intended for use in temporary cardiac pacing or monitoring.

Source page: https://510kreport.com/device/K030556
Methodology: https://510kreport.com/methodology