Class Class II
Neuronaute with IceCap 2 & IceCap 2 Small (K223644)
Description
Neuronaute with IceCap 2 & IceCap 2 Small by Bioserenity, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223644
Clearance Date2023-01-12
Clearance TypeSpecial
Product CodeGWQ
Regulation Number882.1400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223644
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. Neuronaute with IceCap 2 & IceCap 2 Small (K223644) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202334 | Neuronaute | Bioserenity Sas | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243788 | IceCap product line | Bioserenity Medical Devices Group | 2025 |
| K231366 | Neuronaute Plus | Bioserenity Sas | 2023 |
Trace the full predicate network for K223644
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.