# K250515: EpiMonitor

- Pathway: 510(k) (Special)
- Applicant: Empatica S.r.l.
- Decided: Jun 19, 2025 after 118 days
- Product code: POS (Physiological Signal Based Seizure Monitoring System)
- Device class: 2
- Regulation: 21 CFR 882.1580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 40 generations back to K941811 (1994). 416 ancestors in all.
No later device cites it as a predicate yet.
2 of 417 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232915: EpiMonitor, Empatica S.r.l. (2024) Summary page 6.

## Indications for use
EpiMonitor is a prescription only medical device system composed of a wearable device “EmbracePlus” and paired mobile software application “EpiMonitor” intended as an adjunct to seizure monitoring in adults and children aged 6 and up in a home environment or healthcare facilities. The device is worn on the wrist and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with either primary or secondary generalized tonic clonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, the wearable device component of EpiMonitor sends a command to a paired mobile device where the EpiMonitor App is programmed to initiate an alert to a designated caregiver. The EpiMonitor app incorporates additional detection sensitivity modes, "high" for use during periods of rest or sleeping or "low" for use during periods of low-intensity activity, in order to reduce false alarm incidents. EpiMonitor records, stores and transmits accelerometers, EDA, Peripheral skin temperature and activity data for subsequent retrospective review by a trained healthcare professional via a cloud-based software.

Source page: https://510kreport.com/device/K250515
Methodology: https://510kreport.com/methodology