# K022909: Nikomed Trace 1 Ecg Electrodes

- Pathway: 510(k) (Special)
- Applicant: Nikomed U.S.A., Inc.
- Decided: Jan 9, 2003 after 128 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Nikomed ECG Electrodes: named in the summary without a submission number

## Indications for use
The Nikomed TRACE lTM ECG Electrode is indicated for use on the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. (CFR 870.2360)

Source page: https://510kreport.com/device/K022909
Methodology: https://510kreport.com/methodology