# K031694: Modification to Eeg Monitor with Bis, Model a-2000

- Pathway: 510(k) (Traditional)
- Applicant: Aspect Medical Systems, Inc.
- Decided: Aug 29, 2003 after 88 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: 3 generations back to K963644 (1996). 7 ancestors in all.
304 later devices descend from it; 1 cites it directly.
0 of 312 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011534: Eeg Mis Monitor Model # a-2000; Bis Engine, Aspect Medical Systems, Inc. (2001) Summary page 1.
- K012466: Bis/Eeg Module, General Electric Medical Systems Information Techn (2001) Summary page 1.

## Most influential descendants
- 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
- K050141: The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors (2005), 250 descendants of its own

## Indications for use
The Aspect A-2000 EEG Monitor with BIS is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS Monitor 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 may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

Source page: https://510kreport.com/device/K031694
Methodology: https://510kreport.com/methodology