510(k) · Cleared
ClearedEpiWatch Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epiwatch, Inc. · POS Physiological Signal Based Seizure Monitoring System
Cleared on Mar 7, 2025 as substantially equivalent to K181861 (Empatica S.r.l., 2018) after a 114-day review. Its family tree reaches back 3 generations to 2017.
- Decided
- Mar 7, 2025
- Review
- 114 days
- Class
- Class II
- Product code
- POS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 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.
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 8 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 1 of the 3 ancestors has a recall of any class.
- 3 other devices also cite its predicate K181861.
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. 2025, 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 EpiWatch Monitoring System is a prescription, software-only mobile medical application intended for use with a compatible wrist-worn device as an adjunct to seizure monitoring of adults and children ages 5 and up in home or healthcare settings during periods of rest. The EpiWatch Monitoring System continuously records, stores, displays, and transfers data from the compatible wrist-worn device’s built-in physiological-based sensors to support review…
Read the full statement (112 words)
The EpiWatch Monitoring System is a prescription, software-only mobile medical application intended for use with a compatible wrist-worn device as an adjunct to seizure monitoring of adults and children ages 5 and up in home or healthcare settings during periods of rest.
The EpiWatch Monitoring System continuously records, stores, displays, and transfers data from the compatible wrist-worn device’s built-in physiological-based sensors to support review by healthcare professionals, and people with epilepsy (PWE) or at risk of epilepsy.
When the EpiWatch Monitoring System detects and logs physiological patterns associated with generalized tonic-clonic seizures (TCS), the EpiWatch Monitoring System application alerts the user and/or the identified caregiver(s) to notify of detected possible seizure events.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243515: EpiWatch Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243515
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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