# K053011: Pro-Neo Neonatal Ecg Electrode, Models SG15 and SR20

- Pathway: 510(k) (Traditional)
- Applicant: Bio Protech, Inc.
- Decided: Dec 14, 2005 after 49 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
Longest line of descent: 1 generation back to K000206 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000206: Pals Neonatal Pediatric Ecg Electrode, Models PN100, PN200, Axelgaard Mfg. Co., Ltd. (2000) Summary page 1.

## Most influential descendants
- K080106: Skintact Pre-Wired Ecg Electrodes with Conductive Adhesive (2008), 0 descendants of its own

## Indications for use
The PRONEO Neonatal ECG Electrodes are designed for use whenever cardiac monitoring for neonatal or pediatric patients is deemed or desirable by trained medical or emergency personnel. This electrode is for use on neonatal and pediatric patients. The PRONEO Neonatal ECG Electrodes are non-sterile and are to be used on intact (uninjured) skin.

Source page: https://510kreport.com/device/K053011
Methodology: https://510kreport.com/methodology