# K243515: EpiWatch Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Epiwatch, Inc.
- Decided: Mar 7, 2025 after 114 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: 3 generations back to DEN140033 (2017). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181861: Embrace, Empatica S.r.l. (2018) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K243515
Methodology: https://510kreport.com/methodology