# K072286: Bis Eeg Vista Monitor System and Bisx

- Pathway: 510(k) (Traditional)
- Applicant: Aspect Medical Systems, Inc.
- Decided: Nov 20, 2007 after 96 days
- Product code: OLW (Index-Generating Electroencephalograph Software)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K963644 (1996). 13 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052362: Bis Eeg Monitor, Model a-3000, Aspect Medical Systems, Inc. (2005) Summary page 1.
- K963644: A-1000 Eeg Monitor and a-1050 Eeg Monitor, Aspect Medical Systems, Inc. (1996) Summary page 1.
- K062613: Bis Eeg Monitor View, Aspect Medical Systems, Inc. (2007) Summary page 1.
- K052981: Bis Eeg Monitor, Model BISX4, Aspect Medical Systems, Inc. (2005) Summary page 1.
- K040183: BISX, Aspect Medical Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K254213: Pascall Sensor Unit (PSU1) (2026), 0 descendants of its own
- K260907: BIS™ Advance pEEG Module (2026), 0 descendants of its own

## Recalls of this device
- Jul 26, 2018 · Class II · Z-2958-2018: Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems

## Indications for use
The BISx is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in their proper use. The BISx, and all its associated parameters, 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 Index, one of the BISx output parameters, may be used as an aid in monitoring the effects of certain anesthetic agents; and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time. Use of the BIS Index for monitoring to help guide anesthetic administration may be associated with the reduction of incidence of awareness with recall in adults during general anesthesia and sedation.

Source page: https://510kreport.com/device/K072286
Methodology: https://510kreport.com/methodology