# K002734: Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106

- Pathway: 510(k) (Special)
- Applicant: Aspect Medical Systems, Inc.
- Decided: Sep 14, 2000 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
No predicates in its family tree.
21 later devices descend from it; 6 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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
- K062692: Bis Bilateral Sensor (2006), 7 descendants of its own
- K050835: Datex-Ohmeda S/5TM Entropy Module, E-Entropy and Accessories (2005), 7 descendants of its own
- K041670: Bis Pediatric Sensor (2004), 7 descendants of its own

Source page: https://510kreport.com/device/K002734
Methodology: https://510kreport.com/methodology