EpiMonitor
FDA 510(k) K250515 · Empatica S.r.l.
510(k) numberK250515
Submission
- Device name
- EpiMonitor
- Applicant
- Empatica S.r.l.
Milano, IT - Received
- February 21, 2025
- Decision date
- June 19, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- POS – Physiological Signal Based Seizure Monitoring System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1580
- Specialty
- Neurology
The Physiological signal based seizure monitoring system is a prescription device that uses physiological signal to identify abnormal physiological activity that may be associated with a seizure. The System does not predict seizure onsets, and is not intended as a standalone seizure monitoring device.
Other 510(k)s with product code POS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251506 | Nelli (Version 7.11)POS · Traditional | Neuro Event Labs OY | 11/21/2025SE |
| K243199 | NightWatch+ USPOS · Traditional | Livassured BV | 07/12/2025SE |
| K243515 | EpiWatch Monitoring SystemPOS · Traditional | Epiwatch, Inc. | 03/07/2025SE |
| K232915 | EpiMonitorPOS · Traditional | Empatica S.r.l. | 02/15/2024SE |
| K200276 | SPEAC SystemPOS · Traditional | Brain Sentinel, Inc. | 02/06/2021SE |
| K182180 | SPEAC SystemPOS · Traditional | Brain Sentinel, Inc. | 05/11/2019SE |
| K181861 | EmbracePOS · Traditional | Empatica S.r.l. | 12/20/2018SE |
| K172935 | EmbracePOS · Traditional | Empatica S.r.l. | 01/26/2018SE |
More from Empatica S.r.l.
| 510(k) | Device | Decision |
|---|---|---|
| K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…GYD · Traditional | 08/14/2026SE |
| K252981 | EmbraceMiniLEL · Traditional | 12/22/2025SE |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI · Traditional | 06/06/2025SE |
| K232915 | EpiMonitorPOS · Traditional | 02/15/2024SE |
| K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI · Traditional | 10/30/2023SE |
| K221282 | Empatica Health Monitoring PlatformDQA · Traditional | 11/20/2022SE |
| K181861 | EmbracePOS · Traditional | 12/20/2018SE |
| K172935 | EmbracePOS · Traditional | 01/26/2018SE |
Questions and answers
When was EpiMonitor cleared by the FDA?
EpiMonitor (K250515) received a 510(k) decision of Substantially Equivalent on June 19, 2025, 118 days after the submission was received.
What is the product code of K250515?
The FDA product code is POS – Physiological Signal Based Seizure Monitoring System, a Class II (moderate risk) device regulated under 21 CFR 882.1580.