# K994330: Aspect Medical Systems Eeg Sensor, Model 186-0076

- Pathway: 510(k) (Special)
- Applicant: Aspect Medical Systems, Inc.
- Decided: Jan 18, 2000 after 26 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 K761301 (1977). 3 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961821: Aspect Medical Systems Zipprep Eeg Sensor, Aspect Medical Systems, Inc. (1996) Summary page 1.

## Most influential descendants
- K013389: Datex-Ohmeda S/5 Bis Module, M-Bis and Accessories (2002), 10 descendants of its own
- K023459: Datex-Ohmeda S/5 Entropy Module, M-Entropy and Accessories (2003), 8 descendants of its own
- K050835: Datex-Ohmeda S/5TM Entropy Module, E-Entropy and Accessories (2005), 7 descendants of its own
- K062580: GE Entropy Sensor (REFM1038681) and GE Entropy Cable (Ref M1050784) (2007), 4 descendants of its own
- K061907: Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and Accessories (2008), 2 descendants of its own

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

Source page: https://510kreport.com/device/K994330
Methodology: https://510kreport.com/methodology