# K052362: Bis Eeg Monitor, Model a-3000

- Pathway: 510(k) (Special)
- Applicant: Aspect Medical Systems, Inc.
- Decided: Sep 9, 2005 after 11 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: 6 generations back to K963644 (1996). 10 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030267: Eeg Monitor with Bis, Model a-2000, Aspect Medical Systems, Inc. (2004) Summary page 1.
- K040183: BISX, Aspect Medical Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K062613: Bis Eeg Monitor View (2007), 9 descendants of its own
- K072286: Bis Eeg Vista Monitor System and Bisx (2007), 8 descendants of its own
- K131898: A Series and Q Series Patient Monitors (2014), 2 descendants of its own
- K230693: BIS™ Advance Monitoring System (2024), 1 descendant of its own
- K183687: LifeWindow LW8 Lite (2019), 1 descendant of its own

## Indications for use
The Aspect Medical Systems BIS EEG Monitor, A-3000, 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/K052362
Methodology: https://510kreport.com/methodology