# K182180: SPEAC System

- Pathway: 510(k) (Traditional)
- Applicant: Brain Sentinel, Inc.
- Decided: May 11, 2019 after 271 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: 1 generation back to DEN140033 (2017). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN140033: Companion, Lgch, Inc. (2017) Summary page 4.

## Most influential descendants
- K200276: SPEAC System (2021), 0 descendants of its own

## Indications for use
The SPEAC® System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The System records and stores surface electromyographic (SEMG) data for subsequent review by a trained healthcare professional. The device is to be used on the belly of the biceps muscle to analyze sSEMG signals that may be associated with generalized tonic-clonic (GTC) seizures. 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 sEMG data for subsequent review.

Source page: https://510kreport.com/device/K182180
Methodology: https://510kreport.com/methodology