Class Class II
EVA15 insufflator (K222901)
Description
EVA15 insufflator by Palliare , Ltd., an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222901
Clearance Date2023-01-27
Clearance TypeTraditional
Product CodeHIF
Regulation Number884.1730
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222901
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. EVA15 insufflator (K222901) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202799 | EVA15 | Palliare , Ltd. | 2020 |
| K153513 | Insufflator 50L FM134 | W.O.M. World of Medicine GmbH | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232902 | EVA15 insufflator | Palliare , Ltd. | 2024 |
| K230474 | EVA5 Insufflator | Palliare , Ltd. | 2023 |
Trace the full predicate network for K222901
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.