# K213299: Wireless EEG System

- Pathway: 510(k) (Traditional)
- Applicant: Pascall Systems, Inc.
- Decided: May 11, 2022 after 222 days
- Product code: OLT (Non-Normalizing Quantitative 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 K875179 (1988). 76 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142834: DiscoverEEG System, Model DE-401, Neurowave Systems, Inc. (2015) Summary page 5.
- K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P, Nihon Kohden America, Inc. (2012) Summary page 5.

## Most influential descendants
- K254213: Pascall Sensor Unit (PSU1) (2026), 0 descendants of its own
- K240593: VEEGix EEG System (2024), 0 descendants of its own

## Indications for use
The Pascall Systems, Inc. Wireless EEG System, is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the forehead and wirelessly transmitting the electroencephalographic (EEG) signals for storage and display. The Pascall Systems, Inc. Wireless EEG System, is intended for use in the acquisition of EEG signals, displaying them in real time and storing them for later review and analysis. The Pascall Systems, Inc. Wireless EEG System, is intended for use in a hospital Operating Room, Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings. The Pascall Systems, Inc. Wireless EEG System is indicated for use on patients 18 years of age or older and is to be used by licensed medical professionals that have been adequately trained in the use and interpretation of raw EEG data for determination of brain state during anesthesia. The Pascall Systems, Inc. Wireless EEG System does not provide any diagnostic conclusion about the patient's condition.

Source page: https://510kreport.com/device/K213299
Methodology: https://510kreport.com/methodology