# K220448: Disposable Non-invasive EEG Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Med-Link Electronics Tech Co., Ltd.
- Decided: Jan 19, 2023 after 337 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: 7 generations back to K761301 (1977). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143506: Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3 Electrodes; Bis Quatro Sensor; Bis Pedi-XP Sensor,2-Channel (4 Electrodes); Bis Extend Sensor; Bis Bilateral Sensor,4-Channel (6 Elecrodes); Bis Insight Sensor,Cvi-Enabled,2-Channel (4 Electrodes), Covidien (2015) Summary page 5.
- K062580: GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784), GE Healthcare (2007) Summary page 5.

## Most influential descendants
- K240668: Amydi-med Disposable Non-invasive EEG electrodes (2024), 0 descendants of its own

## Indications for use
Disposable Non-invasive EEG Sensor is applied directly to the patient’s skin to enable recordings of electrophysiological (such as EEG) signals.

Source page: https://510kreport.com/device/K220448
Methodology: https://510kreport.com/methodology