# K091854: Bis Click Sensor/Cable

- Pathway: 510(k) (Traditional)
- Applicant: Aspect Medical Systems, Inc.
- Decided: Jul 2, 2009 after 13 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 K940802 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050313: Bis SRS (Semi-Resuable Sensor), Aspect Medical Systems, Inc. (2005) Summary page 1.
- K002734: Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106, Aspect Medical Systems, Inc. (2000) Summary page 1.

## Indications for use
The BIS Click sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

Source page: https://510kreport.com/device/K091854
Methodology: https://510kreport.com/methodology