# K241160: CAIs Sensor (CAIs-001)

- Pathway: 510(k) (Traditional)
- Applicant: Brainu Co., Ltd.
- Decided: Dec 13, 2024 after 231 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: 3 generations back to K002734 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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.

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

Source page: https://510kreport.com/device/K241160
Methodology: https://510kreport.com/methodology