# K000206: Pals Neonatal Pediatric Ecg Electrode, Models PN100, PN200

- Pathway: 510(k) (Traditional)
- Applicant: Axelgaard Mfg. Co., Ltd.
- Decided: Apr 13, 2000 after 83 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.
28 later devices descend from it; 4 cite it directly.
0 of 29 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
- K033010: BRM2 Brain Monitor (2003), 23 descendants of its own
- K071449: BRM3 Brain Monitor (2007), 15 descendants of its own
- K080217: Component Neuromonitoring System (2008), 14 descendants of its own
- K082886: Zoom-100DC (2009), 11 descendants of its own
- K081551: Twin Neurotrac-Iii (2008), 8 descendants of its own

Source page: https://510kreport.com/device/K000206
Methodology: https://510kreport.com/methodology