# K200276: SPEAC System

- Pathway: 510(k) (Traditional)
- Applicant: Brain Sentinel, Inc.
- Decided: Feb 6, 2021 after 368 days
- Product code: POS (Physiological Signal Based Seizure Monitoring System)
- Device class: 2
- Regulation: 21 CFR 882.1580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN140033 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182180: SPEAC System, Brain Sentinel, Inc. (2019) Summary page 4.

## Indications for use
The SPEAC® System is intended for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The non-EEG Physiological Signal Based Seizure Monitoring System continuously records and stores surface electromyographic (SEMG) data for subsequent review. Trained healthcare professionals may use the electrophysiological SEMG data during a post-hoc review, with other contextual data, to characterize upper-extremity motor activity (UEMA) ipsilateral to the device from other activity. Audio data recorded during seizure monitoring may be available for review by a trained healthcare professional. The device is to be used on the belly of the biceps muscle to analyze sSEMG signals. When sEMG signal patterns associated with a unilateral, appendicular, tonic extension that could be associated with a GTC seizure are detected, the SPEAC System sends adjunctive alarms to alert caregivers. Adjunctive alarms may be disabled by a physician order while continuing to record sSEMG data for subsequent review.

Source page: https://510kreport.com/device/K200276
Methodology: https://510kreport.com/methodology