# K052981: Bis Eeg Monitor, Model BISX4

- Pathway: 510(k) (Special)
- Applicant: Aspect Medical Systems, Inc.
- Decided: Nov 1, 2005 after 8 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Aspect Medical Systems BISx: named in the summary without a submission number

## Most influential descendants
- 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
- K254213: Pascall Sensor Unit (PSU1) (2026), 0 descendants of its own

## Indications for use
The BISx4 is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BISx4 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/K052981
Methodology: https://510kreport.com/methodology