Class Class II
EpiMonitor (K250515)
Description
EpiMonitor by Empatica S.R.L., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250515
Clearance Date2025-06-19
Clearance TypeSpecial
Product CodePOS
Regulation Number882.1580
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250515
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. EpiMonitor (K250515) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232915 | EpiMonitor | Empatica S.r.l. | 2024 |
| K181861 | Embrace | Empatica S.r.l. | 2018 |
Trace the full predicate network for K250515
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.