Class Class II
NeuroEars-Anna™ (K243709)
Description
NeuroEars-Anna™ by Neuroears, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243709
Clearance Date2025-08-25
Clearance TypeTraditional
Product CodeGWN
Regulation Number882.1460
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243709
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. NeuroEars-Anna™ (K243709) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K143607 | I-Portal NOTC, VNG and VOG | Neuro Kinetics, Inc. | 2015 |
| K083603 | I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-... | Neuro Kinetics | 2009 |
Trace the full predicate network for K243709
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.