Class Class II
EXPLORER AIR® II (K222240)
Description
EXPLORER AIR® II by Surgvision GmbH, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222240
Clearance Date2023-02-28
Clearance TypeTraditional
Product CodeIZI
Regulation Number892.1600
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222240
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. EXPLORER AIR® II (K222240) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K214097 | Explorer Air II | Surgvision GmbH | 2022 |
| K210265 | VS3 Iridium Sytem | Visionsense, Ltd. | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K234090 | EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile ... | Surgvision GmbH | 2024 |
Trace the full predicate network for K222240
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.