# K254213: Pascall Sensor Unit (PSU1)

- Pathway: 510(k) (Special)
- Applicant: Pascall Systems, Inc.
- Decided: Aug 19, 2026 after 233 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: 10 generations back to K875179 (1988). 89 ancestors in all.
No later device cites it as a predicate yet.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213299: Wireless EEG System, Pascall Systems, Inc. (2022) Summary page 5.
- K072286: Bis Eeg Vista Monitor System and Bisx, Aspect Medical Systems, Inc. (2007) Summary page 5.

## 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 a physician’s office, laboratory, clinic, or in outpatient 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 under the direction and interpretation of a licensed medical professional. The Pascall Systems, Inc. Wireless EEG System does not provide any diagnostic conclusion about the patient's condition.

Source page: https://510kreport.com/device/K254213
Methodology: https://510kreport.com/methodology