# K011834: Bis Engine

- Pathway: 510(k) (Special)
- Applicant: Aspect Medical Systems, Inc.
- Decided: Jul 10, 2001 after 28 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 K923043 (1992). 2 ancestors in all.
306 later devices descend from it; 1 cites it directly.
0 of 309 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002837: Bis Engine, Aspect Medical Systems, Inc. (2000) Summary page 1.
- K923043: Spectral Eeg Monitor Model A1000, Aspect Medical Systems, Inc. (1992) 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
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/K011834
Methodology: https://510kreport.com/methodology