Class Class II
FlowSaver Blood Return System (K221483)
Description
FlowSaver Blood Return System by Inari Medical, Inc., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221483
Clearance Date2023-02-17
Clearance TypeTraditional
Product CodeCAC
Regulation Number868.5830
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221483
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. FlowSaver Blood Return System (K221483) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210176 | FlowSaver Blood Filter | Inari Medical | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231782 | FlowSaver Blood Return System (80-101) | Inari Medical, Inc. | 2023 |
Trace the full predicate network for K221483
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.