510(k) · Cleared
ClearedSPEAC System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brain Sentinel, Inc. · POS Physiological Signal Based Seizure Monitoring System
Cleared on Feb 6, 2021 as substantially equivalent to K182180 (Brain Sentinel, Inc., 2019) after a 368-day review. Its family tree reaches back 2 generations to 2017.
- Decided
- Feb 6, 2021
- Review
- 368 days
- Class
- Class II
- Product code
- POS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN140033 (2017). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in POS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new POS device
- #1 K232915 EpiMonitorscore 19.5 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K182180 | SPEAC SystemSummary page 4…physiological signal-based seizure monitoring system; Regulation 21 CFR 882.1580 Review Panel Neurodiagnostic Devices; Neurology Predicate Device K182180 Manufacturer Brain Sentinel, Inc. Device Name Brain Sentinel Monitoring and Alerting System Regulation Name… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All POS devicesPOS Physiological Signal Based Seizure Monitoring System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · POS
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · POS
154in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · POS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · POS
1in 2025
MAUDE reports naming product code POS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 4 | 154 | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (155 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200276: SPEAC System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200276
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026