# K012466: Bis/Eeg Module

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Oct 1, 2001 after 61 days
- Product code: OLW (Index-Generating Electroencephalograph Software)
- Device class: 2
- Regulation: 21 CFR 882.1400
- 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 K963644 (1996). 5 ancestors in all.
305 later devices descend from it; 1 cites it directly.
0 of 311 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974496: A-2000 Eeg Monitor with Bis, Aspect Medical Systems, Inc. (1998) Summary page 1.
- K923043: Spectral Eeg Monitor Model A1000, Aspect Medical Systems, Inc. (1992) Summary page 1.
- K011834: Bis Engine, Aspect Medical Systems, Inc. (2001). Our OCR of the scanned summary read K011843, FDA’s number for Genzyme Direct-Amylase Test Reagent (Genzyme Corp.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Aspect Medical Systems, Inc. EEG Monitor with BIS Engine”.

## Most influential descendants
- K031694: Modification to Eeg Monitor with Bis, Model a-2000 (2003), 304 descendants of its own
- K030267: Eeg Monitor with Bis, Model a-2000 (2004), 303 descendants of its own
- K040183: BISX (2004), 274 descendants of its own
- K041235: Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors (2004), 252 descendants of its own
- K042845: The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors (2004), 251 descendants of its own

## Indications for use
The BIS/EEG Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS/EEG Module is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS/EEG Module is intended to monitor the Bispectral index (BIS), a processed EEG variable which may be used as an aid in monitoring the effects of certain anesthetic agents.

Source page: https://510kreport.com/device/K012466
Methodology: https://510kreport.com/methodology