Class Class II
Neuralytix iD3 System (NTX-9001) (K243636)
Description
Neuralytix iD3 System (NTX-9001) by Neuralytix, LLC, an FDA 510(k) cleared ear, nose, throat device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243636
Clearance Date2025-06-26
Clearance TypeTraditional
Product CodePDQ
Regulation Number874.1820
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243636
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. Neuralytix iD3 System (NTX-9001) (K243636) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K173526 | SENTIO MMG Gen 2 | Medos International SARL | 2018 |
Trace the full predicate network for K243636
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.