# K950473: Disposable Ecg Monitoring Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Nikomed U.S.A., Inc.
- Decided: Dec 12, 1995 after 312 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K990113: Disposable Ecg Monitoring Electrodes, Models 4500,4530, 4533, 4539, 4540, and 4560 (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K950473
Methodology: https://510kreport.com/methodology