# K151576: Neon EEG

- Pathway: 510(k) (Traditional)
- Applicant: Incereb, Ltd.
- Decided: Sep 29, 2015 after 110 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002734 (2000). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062692: Bis Bilateral Sensor, Aspect Medical Systems, Inc. (2006) Summary page 4.
- K041670: Bis Pediatric Sensor, Aspect Medical Systems, Inc. (2004) Summary page 4.

## Most influential descendants
- K243788: IceCap product line (2025), 0 descendants of its own

## Indications for use
The NEON EEG is intended to be applied directly to the patient's scalp to enable recordings of electrophysiological signals (such as EEG) on infants from birth. The NEON EEG is indicated for single use only and should be replaced after 12 hours of use. The NEON EEG is not indicated for use with electro stimulation equipment.

Source page: https://510kreport.com/device/K151576
Methodology: https://510kreport.com/methodology