# K974496: A-2000 Eeg Monitor with Bis

- Pathway: 510(k) (Traditional)
- Applicant: Aspect Medical Systems, Inc.
- Decided: Feb 6, 1998 after 70 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: 1 generation back to K963644 (1996). 1 ancestor in all.
337 later devices descend from it; 6 cite it directly.
0 of 339 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963644: A-1000 Eeg Monitor and a-1050 Eeg Monitor, Aspect Medical Systems, Inc. (1996) Summary page 1.

## Most influential descendants
- K012466: Bis/Eeg Module (2001), 305 descendants of its own
- 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

## Indications for use
The Aspect A-2000 EEG Monitor with BIS is intended to monitor the state of the brain by data acquisition of EEG signals in the intensive care unit, operating room and for clinical research. The BIS, a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents.

Source page: https://510kreport.com/device/K974496
Methodology: https://510kreport.com/methodology