Class Class II
swiftPro System (K222388)
Description
swiftPro System by Emblation , Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222388
Clearance Date2023-05-04
Clearance TypeTraditional
Product CodeNEY
Regulation Number878.4400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222388
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. swiftPro System (K222388) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181941 | Swift System | Emblation , Ltd. | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250718 | swiftPro System (SWF-SPS); Swift System (SWF-SYS) | Emblation Limited | 2025 |
| K240518 | swiftPro™ System | Emblation Limited | 2024 |
Trace the full predicate network for K222388
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.