De Novo · Granted
GrantedCompanion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lgch, Inc. · POS Physiological Signal Based Seizure Monitoring System
Granted on Feb 16, 2017 as a new device type through De Novo after an 829-day review. 9 later devices descend from it.
- Decided
- Feb 16, 2017
- Review
- 829 days
- Class
- Class II
- Product code
- POS
- Recalls
- None
9 later devices descend from it, 2 citing it directly.
- This deviceDEN140033 CompanionLgch, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK172935 EmbraceEmpatica S.r.l. · 2018
- Descendant · 2 generations on · 5 of its ownK181861 EmbraceEmpatica S.r.l. · 2018 · Recalled
- Descendant · 3 generations on · 1 of its ownK232915 EpiMonitorEmpatica S.r.l. · 2024
- Descendant · cites it directly · 1 of its ownK182180 SPEAC SystemBrain Sentinel, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK251506 Nelli (Version 7.11)Neuro Event Labs OY · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K172935EmbraceEmpatica S.r.l. · 2018 · cites it directly6descendants
- K181861EmbraceEmpatica S.r.l. · 2018 · 2 generations on5descendants
- K232915EpiMonitorEmpatica S.r.l. · 2024 · 3 generations on1descendant
- K182180SPEAC SystemBrain Sentinel, Inc. · 2019 · cites it directly1descendant
- K251506Nelli (Version 7.11)Neuro Event Labs OY · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN140033 | Companion | Lgch, Inc. | 2017 | — |
| +1 | K172935 | Embrace | Empatica S.r.l. | 2018 | — |
| +2 | K181861 | Embrace | Empatica S.r.l. | 2018 | 1 |
| +3 | K232915 | EpiMonitor | Empatica S.r.l. | 2024 | — |
| +1 | K182180 | SPEAC System | Brain Sentinel, Inc. | 2019 | — |
| +3 | K251506 | Nelli (Version 7.11) | Neuro Event Labs OY | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K172935 (Empatica S.r.l., 2018) has gone furthest, with 6 descendants of its own.
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. 2017, 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 Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The device is to be used on the belly of the biceps muscle to analyze surface electromyographs (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures and to provide an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN140033 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN140033: Companion.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN140033
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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