# K230693: BIS™ Advance Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Feb 26, 2024 after 350 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: 9 generations back to K963644 (1996). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072286: Bis Eeg Vista Monitor System and Bisx, Aspect Medical Systems, Inc. (2007) Summary page 5.

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

## Indications for use
The BIS™ Advance Monitoring System is intended for monitoring the state of the brain by data acquisition of EEG signals under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS™ Advance Monitoring System, and all its associated parameters, is intended for use on adults and pediatric patients (4 years old and above) within a hospital or medical facility. For Adult patients, the BIS™ Index, one of the BIS™ Advance Monitoring System's output parameters, may be used to guide anesthetic administration of desflurane, isoflurane, propofol and sevoflurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain. The use of the BIS™ Index for monitoring may be associated with the following when used with propofol anesthesia: reduction in primary anesthetic use; reduction in emergence and recovery time; and reduction in incidence of awareness with recall. For pediatric patients, ages 4 and above, the BIS™ Index, one of the BIS™ Advance Monitoring System's output parameters, may be used to guide anesthetic administration of sevoflurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain. The use of the BIS™ Index in pediatric patients, when used with sevoflurane anesthesia, has demonstrated a reduction in primary anesthetic use.

Source page: https://510kreport.com/device/K230693
Methodology: https://510kreport.com/methodology