# K003804: Sensi-Prema Neonatal Ecg Electrodes, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801

- Pathway: 510(k) (Abbreviated)
- Applicant: Niko Medical Products
- Decided: Aug 30, 2001 after 265 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K101685: IP-SET (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K003804
Methodology: https://510kreport.com/methodology