Class Class II
Polaris Valve Electronic Reading Instrument (K222422)
Description
Polaris Valve Electronic Reading Instrument by Sophysa, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222422
Clearance Date2023-02-02
Clearance TypeTraditional
Product CodeJXG
Regulation Number882.5550
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222422
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. Polaris Valve Electronic Reading Instrument (K222422) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K141227 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE... | Sophysa SA | 2015 |
Trace the full predicate network for K222422
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.