Class Class II
Volumat Line (K220301)
Description
Volumat Line by Fresenius Kabi, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK220301
Clearance Date2023-06-02
Clearance TypeTraditional
Product CodeFPA
Regulation Number880.5440
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220301
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. Volumat Line (K220301) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210073 | Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump,... | Fresenius Kabi AG | 2022 |
| K203609 | Intravascular Administration Sets | Baxter Healthcare Corporation | 2021 |
| K121613 | AGILIA INFUSION SYSTEM | Fresenius Kabi AG | 2013 |
Trace the full predicate network for K220301
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.