# K231457: SPARK Scan

- Pathway: 510(k) (Traditional)
- Applicant: Spark Neuro, Inc.
- Decided: Aug 18, 2023 after 91 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- 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: 3 generations back to K964280 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143233: Mitsar-EEG, Mitsar Co., Ltd. (2015) Summary page 4.

## Indications for use
The SPARK Scan is intended to acquire, display, and store the electrical activity of a patient’s brain obtained by placing two or more electrodes on the head to aid in diagnosis.

Source page: https://510kreport.com/device/K231457
Methodology: https://510kreport.com/methodology