510(k) · Cleared
Recalled · Class II · 2023Embrace
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Empatica S.r.l. · POS Physiological Signal Based Seizure Monitoring System
Cleared on Dec 20, 2018 as substantially equivalent to K172935 (Empatica S.r.l., 2018) after a 161-day review. Its family tree reaches back 2 generations to 2017. 5 later devices descend from it. It has been recalled once.
- Decided
- Dec 20, 2018
- Review
- 161 days
- Class
- Class II
- Product code
- POS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN140033 (2017). 5 later devices descend from it, 4 citing it directly.
- Root · 2 generations backDEN140033 CompanionLgch, Inc. · 2017
- 1 generation backK172935 EmbraceEmpatica S.r.l. · 2018
- This deviceK181861 EmbraceEmpatica S.r.l. · 2018
- Descendant · cites it directly · 1 of its ownK232915 EpiMonitorEmpatica S.r.l. · 2024
- Descendant · cites it directly · 0 of its ownK251506 Nelli (Version 7.11)Neuro Event Labs OY · 2025
- Descendant · cites it directly · 0 of its ownK243199 NightWatch+ USLivassured BV · 2025
- Descendant · 2 generations on · 0 of its ownK250515 EpiMonitorEmpatica S.r.l. · 2025
- Descendant · cites it directly · 0 of its ownK243515 EpiWatch Monitoring SystemEpiwatch, Inc. · 2025
Most influential descendants
Showing 5 of 5 · See all- K232915EpiMonitorEmpatica S.r.l. · 2024 · cites it directly1descendant
- K251506Nelli (Version 7.11)Neuro Event Labs OY · 2025 · cites it directly0descendants
- K243199NightWatch+ USLivassured BV · 2025 · cites it directly0descendants
- K250515EpiMonitorEmpatica S.r.l. · 2025 · 2 generations on0descendants
- K243515EpiWatch Monitoring SystemEpiwatch, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN140033 | Companion | Lgch, Inc. | 2017 | — |
| −1 | K172935 | Embrace | Empatica S.r.l. | 2018 | — |
| 0 (this device) | K181861 | Embrace | Empatica S.r.l. | 2018 | — |
| +1 | K232915 | EpiMonitor | Empatica S.r.l. | 2024 | — |
| +1 | K251506 | Nelli (Version 7.11) | Neuro Event Labs OY | 2025 | — |
| +1 | K243199 | NightWatch+ US | Livassured BV | 2025 | — |
| +2 | K250515 | EpiMonitor | Empatica S.r.l. | 2025 | — |
| +1 | K243515 | EpiWatch Monitoring System | Epiwatch, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 4 | 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 |
|---|---|---|---|
| * | K172935 | EmbraceSummary page 5…EG physiological signal based seizure monitoring system Device Classification: 21 CFR 882.1580, Product Code POS Predicate Device: Embrace, K172935 Predicate Device Classification: 21 CFR 882.1580, Product Code POS Device Description: The Embrace is a wearabl… | 2018 |
What descends from it? (5)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 13, 2023 | Class II | Z-0159-2024 | Device Design | May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 11 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K232915 (Empatica S.r.l., 2024) has gone furthest, with 1 descendant 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. 2018, 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 Embrace is a prescription only device that is indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. The device is worn on the wrist and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with generalized tonic clonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected…
Read the full statement (118 words)
The Embrace is a prescription only device that is indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. The device is worn on the wrist and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with generalized tonic clonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, Embrace sends a command to a paired wireless device that is programmed to initiate an alert to a designated caregiver. The System records and stores data from Accelerometer, EDA, and Temperature sensors for subsequent review by a trained healthcare professional.
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/K181861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181861: Embrace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181861
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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