Class Class II
RGS; RGS Mini (K222702)
Description
RGS; RGS Mini by Genesis Air, Inc., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222702
Clearance Date2023-06-02
Clearance TypeTraditional
Product CodeFRA
Regulation Number880.6500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222702
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. RGS; RGS Mini (K222702) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212644 | Aura Storm | Invictus Lighting | 2022 |
Trace the full predicate network for K222702
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.