# K062613: Bis Eeg Monitor View

- Pathway: 510(k) (Special)
- Applicant: Aspect Medical Systems, Inc.
- Decided: Jun 18, 2007 after 286 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: 7 generations back to K963644 (1996). 11 ancestors in all.
9 later devices descend from it; 1 cites 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)
- K052362: Bis Eeg Monitor, Model a-3000, Aspect Medical Systems, Inc. (2005) Summary page 1.

## 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
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; 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 BIS 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/K062613
Methodology: https://510kreport.com/methodology