Class Class II
Falcon HST (K242447)
Description
Falcon HST by Compumedics Limited, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242447
Clearance Date2025-02-20
Clearance TypeTraditional
Product CodeOLV
Regulation Number882.1400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242447
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. Falcon HST (K242447) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K172986 | Zmachine Synergy | Consolidated Research of Richmond, ... | 2017 |
| K101830 | ZMACHINE, MODEL DT-100 | Consolidated Research of Richmond, ... | 2011 |
Trace the full predicate network for K242447
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.