Class Class II
Felix NeuroAI System (K250096)
Description
Felix NeuroAI System by Fasikl Incorporated, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250096
Clearance Date2025-07-01
Clearance TypeTraditional
Product CodeQBC
Regulation Number882.5897
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250096
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. Felix NeuroAI System (K250096) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222237 | Cala kIQ | Cala Health, Inc. | 2022 |
| K203288 | Cala Trio | Cala Health, Inc. | 2021 |
Trace the full predicate network for K250096
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.