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 May 11, 2019 as substantially equivalent to DEN140033 (Lgch, Inc., 2017) after a 271-day review. Its family tree reaches back 1 generation to 2017. 1 later device descends from it.
- Decided
- May 11, 2019
- Review
- 271 days
- Class
- Class II
- Product code
- POS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN140033 (2017). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K200276SPEAC SystemBrain Sentinel, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN140033 | Companion | Lgch, Inc. | 2017 | — |
| 0 (this device) | K182180 | SPEAC System | Brain Sentinel, Inc. | 2019 | — |
| +1 | K200276 | SPEAC System | Brain Sentinel, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
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 |
|---|---|---|---|
| * | DEN140033 | CompanionSummary page 4…G physiological signal-based seizure monitoring system; Regulation 21 CFR 882.1580 Review Panel Neurodiagnostic Devices; Neurology Predicate Device DEN140033 Manufacturer Brain Sentinel, Inc. Device Name Brain Sentinel Monitoring and Alerting System Regulation Name… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200276 | SPEAC System | 2021 | 0 |
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?
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. 2019, 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 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…
Read the full statement (116 words)
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.
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/K182180 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182180: 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/K182180
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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